chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic benefit; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The reporter stated that she had a friend who described that her grandmother experienced a reduction in post herpetic neuralgia from a shingles outbreak after receiving the Shingrix vaccine, which led to unexpected therapeutic effect. The reporter was unable to provide any additional information. This was one of the 4 cases, reported by the same reporter. This case has been linked with case US2019125903, US2019125910, US2019125912, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Nausea; Vomiting; Diarrhea; Headache; This is a spontaneous report from a contactable physician, consumer and healthcare professional. These contactable physician, consumer and healthcare professional reported similar events for two patients. This is the first of the two reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Lot number: AR9309; Expiration date: Feb2021), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had fever, body aches, nausea, vomiting, diarrhea and headache. The outcome of the events, fever, body aches, nausea, vomiting, diarrhea and headache, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303620 same reporter/drug/events, different patient
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Fever; Body aches; Nausea; Vomiting; Diarrhea; Headache; This is a spontaneous report from a contactable physician, consumer and healthcare professional. These contactable physician, consumer and healthcare professional reported similar events for two patients. This is the first of the two reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Lot number: AR9309; Expiration date: Feb2021), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had fever, body aches, nausea, vomiting, diarrhea and headache. The outcome of the events, fever, body aches, nausea, vomiting, diarrhea and headache, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303620 same reporter/drug/events, different patient
Sex: U
Vaccine: MENB
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Nausea; Vomiting; Diarrhea; Headache; This is a spontaneous report from a contactable physician, consumer and healthcare professional. These contactable physician, consumer and healthcare professional reported similar events for two patients. This is the second of the two reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Lot number: AR9309; Expiration date: Feb2021), via an unspecified route of administration on an unspecified date at single dose for immunization. On an unspecified date, the patient had fever, body aches, nausea, vomiting, diarrhea and headache. The outcome of the events, fever, body aches, nausea, vomiting, diarrhea and headache, was unknown. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303263 same reporter/drug, different patient, similar event
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Fever; Body aches; Nausea; Vomiting; Diarrhea; Headache; This is a spontaneous report from a contactable physician, consumer and healthcare professional. These contactable physician, consumer and healthcare professional reported similar events for two patients. This is the second of the two reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Lot number: AR9309; Expiration date: Feb2021), via an unspecified route of administration on an unspecified date at single dose for immunization. On an unspecified date, the patient had fever, body aches, nausea, vomiting, diarrhea and headache. The outcome of the events, fever, body aches, nausea, vomiting, diarrhea and headache, was unknown. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303263 same reporter/drug, different patient, similar event
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: The customer reported a reaction of swelling and pain; The customer reported a reaction of swelling and pain; Patient developed Redness and swelling; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, NDC number: 0005197102, Lot Number: X91013 and Expiry date: Jan2021, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The consumer mentioned that a customer reported a reaction of swelling and pain on unspecified date. The patient developed redness and swelling. Outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: pt complained of redness and swelling. doctor was seen and given pcn antibiotic
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache, body ache, dizzy, nausea.  Left upper arm at the injection site is swollen, red and painful.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain
Clinical narrative: Headache, body ache, dizzy, nausea.  Left upper arm at the injection site is swollen, red and painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Night of the administration woke up with a low grade fever.  Following day extreme fatigue and headache.  2nd day post administration rash on torso,  backside, waist,  behind both entire legs  and residual headache.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Upon calling pt to remind her to get the second immunization, pt informed me that she had a severe immunization site reaction to the immunization. She stated that she had extreme swelling that was about 3 inches in diameter, redness, hotness, and itching. The symptoms started the day after the immunization was given and lasted for about one week. Pt did not contact any healthcare providers about the reaction and did nothing to treat it. She just waited for it to resolve on its own.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Gave a Pentacel instead of a Pediarix
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Abdominal X-ray, Constipation, Rash, Urine analysis
Clinical narrative: The patient reported a rash which developed the evening of 7/9/19. She described a bluish colored lace pattern on her abdomen which spread to arms and legs. There was no itching or fever. She was seen in the emergency room 7/14/19. Abdominal xray and urinalysis were performed and she was treated with Miralax for constipation. She followed up with me (Dr.) on 7/19/19. The lace-patterned rash was still present on her abdomen, forearms, and anterior/inner thighs although improved from photos mother showed me from her cell phone. We continued to treat constipation, ordered imaging of the abdomen and referred to Allergy and immunology for further recommendations regarding future vaccinations.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, fever & fatigue Acetaminophen 650 mg once take now, one dose
Age: 29.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Please see attached as per patient (1) Got vaccinated on Wednesday (2) Felt a bit of arm pain until end of Thursday (3) Friday, started feelin glads swell (4) Saturday, I also started to feel joint pain and fatigue (5) Sunday night, I got a high fever (6) Monday, I used homeopathic medicine to lower the fever (it ranged from as low as 98.1 to 100.4 approx). I got really bad chills when the fever spiked up again. (7) Tuesday, all symptoms continued, range of fever dropped a but (8) Wednesday morning fever was at is highest checked twice fever ranged from 100.1 to 101.4. All other symptoms continues. Homeopathic pills
Age: 29.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Please see attached as per patient (1) Got vaccinated on Wednesday (2) Felt a bit of arm pain until end of Thursday (3) Friday, started feelin glads swell (4) Saturday, I also started to feel joint pain and fatigue (5) Sunday night, I got a high fever (6) Monday, I used homeopathic medicine to lower the fever (it ranged from as low as 98.1 to 100.4 approx). I got really bad chills when the fever spiked up again. (7) Tuesday, all symptoms continued, range of fever dropped a but (8) Wednesday morning fever was at is highest checked twice fever ranged from 100.1 to 101.4. All other symptoms continues. Homeopathic pills
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Disturbance in attention, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: I woke up the day after getting the shingrix and pneumovax shots, feeling totally like crap, and felt worse as the day wore on. I was achy and my stomach was upset, my head ached and my neck was stiff and sore, and I couldn't focus on anything. My fever got up to 101.7. I contacted my insurance plan's teledoctor service. The doctor said that it was the shingrix shot and she sees a lot of it, and told me to take both ibuprofen and tylenol. I took aspirin and tylenol. This caused me to miss work on Monday, and interfered with my productivity at work on Tuesday. It cleared up slowly and was gone by Tuesday afternoon. 7/9 (72 hours) I had such brain fog I couldn't remember the word for hard drive. My job is testing computer RAM and hard drives.  As a result of this I doubt I'm going to get the second shot. It isn't worth it! I wasn't this sick when I had CHICKEN POX, nor the last two times I had the flu! My sister's had shingles, and to the shot, she said, NOPE!
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pyrexia
Clinical narrative: I woke up the day after getting the shingrix and pneumovax shots, feeling totally like crap, and felt worse as the day wore on. I was achy and my stomach was upset, my head ached and my neck was stiff and sore, and I couldn't focus on anything. My fever got up to 101.7. I contacted my insurance plan's teledoctor service. The doctor said that it was the shingrix shot and she sees a lot of it, and told me to take both ibuprofen and tylenol. I took aspirin and tylenol. This caused me to miss work on Monday, and interfered with my productivity at work on Tuesday. It cleared up slowly and was gone by Tuesday afternoon. 7/9 (72 hours) I had such brain fog I couldn't remember the word for hard drive. My job is testing computer RAM and hard drives.  As a result of this I doubt I'm going to get the second shot. It isn't worth it! I wasn't this sick when I had CHICKEN POX, nor the last two times I had the flu! My sister's had shingles, and to the shot, she said, NOPE!
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient given Hep A adult vaccine instead of Hep A pedi/adolescent vaccine.  Report filed, Patient's  guardian notified, state notified,  PCP and management notified.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Asthenia, Hypersomnia, Lethargy, Nausea
Clinical narrative: On Saturday evening around 11:30 (about 38 hours after the MMR vaccine) patient began came into our room suddenly and complained of stomach pain and began vomiting. She went back to bed after the episode, but then woke up to vomit again 2-3 more times that night. The next morning (Sunday)  she awoke still  complaining of stomach pain. We took her temp and it was 100.8. She had a few more vomiting episodes that day. Patient stayed home with her mother on Monday and was low energy and complaining of stomach pain throughout the day, but no vomiting. On monday she still had an elevated temperature, 99.8. On Tuesday she stayed with her father at his office and again was complaining of stomach pain all day. She went into the bathroom a few times saying she had to vomit, but nothing came up. She also took a 3 hour nap that day which is highly unusual for her. On Wednesday she was still complaining of stomach pain and was acting lethargic all day. On Thursday she went to work with her mother and she seemed to be more normal throughout the day, but wanted to go to be early that evening. Today, Friday, she awoke still complaining of stomach pain.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: On Saturday evening around 11:30 (about 38 hours after the MMR vaccine) patient began came into our room suddenly and complained of stomach pain and began vomiting. She went back to bed after the episode, but then woke up to vomit again 2-3 more times that night. The next morning (Sunday)  she awoke still  complaining of stomach pain. We took her temp and it was 100.8. She had a few more vomiting episodes that day. Patient stayed home with her mother on Monday and was low energy and complaining of stomach pain throughout the day, but no vomiting. On monday she still had an elevated temperature, 99.8. On Tuesday she stayed with her father at his office and again was complaining of stomach pain all day. She went into the bathroom a few times saying she had to vomit, but nothing came up. She also took a 3 hour nap that day which is highly unusual for her. On Wednesday she was still complaining of stomach pain and was acting lethargic all day. On Thursday she went to work with her mother and she seemed to be more normal throughout the day, but wanted to go to be early that evening. Today, Friday, she awoke still complaining of stomach pain.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE STARTED SWELLING SAME DAY ABOUT SIZE OF A NICKEL AND WAS HOT TO TOUCH, TODAY SITE IS SWOLLEN TO SIZE OF  ORANGE AND HOT TO TOUCH.  IS GOING TO ALTERNATE TYLENOL AND IBUPROFEN.  I WILL CALL AND GET UPDATES THRU OUT THIS WEEKEND.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: The pharmacist said I might feel like I had a bad case of the flu and that's exactly what it felt like.  She told me if I was going to have a reaction it would occur about 5/6 hours after receiving the shot and then last for about 24 hours and she was spot on with the timetable.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Woke up with flu like symptoms. Chills and body aches
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: patient had a syncope episode immediately after vaccine given. Woke easily within minutes of episode. Vitals stable after episode, evaluated by provider, waited an additional 20 minutes to make sure no further reaction and was released with mom.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Borrelia test, Full blood count normal, Hypoaesthesia, Laboratory test
Clinical narrative: Reports pain to left  hand, joints and wrist as well as edema. Within 24 hours the right hand had the same symptoms. He reports pain to all joints in bilateral hands with numbness. He seen his provider 3 days ago and was started on Prednisone 50 mg X 7 days. He reports significant improvement by day 3 on medication.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Metabolic function test normal, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Reports pain to left  hand, joints and wrist as well as edema. Within 24 hours the right hand had the same symptoms. He reports pain to all joints in bilateral hands with numbness. He seen his provider 3 days ago and was started on Prednisone 50 mg X 7 days. He reports significant improvement by day 3 on medication.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Facial paralysis, Immediate post-injection reaction, Pain in extremity, Rash
Clinical narrative: facial paralysis on the one side of his face; rash; pain in the bottom of the feet; pain in his joints; This spontaneous report was received from a consumer referring to his father who was 58 years old. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as "none".  The patient's historical drug included two shots of Zoster Vaccine Recombinant, Adjuvanted(SHINGRIX) given on unknown dates in October 2018.   On an unknown date in December 2018, the patient was vaccinated with one shot of Zoster Vaccine Live(ZOSTAVAX), one dosage form (strength, expiry date, lot number, frequency, route of administration were unknown) to prevent shingles(prophylaxis).   On an unknown date in December 2018, the patient experienced pain in the bottom of the feet (pain in extremity), and pain in his joints(arthralgia) immediately after receiving the Zoster Vaccine Live(ZOSTAVAX) shot and the pain was random and it comes and goes. About two months ago (May 2019), the patient experienced rash. On an unknown date, the patient experienced facial paralysis on the one side of his face.  On 01-JUL-2019, the patient was seen by a physician (sought medical attention) for the facial paralysis and no treatment was provided. There were no lab diagnostics/studies were performed. No product quality complaint (PQC) was reported.   Outcome of the events pain in extremity, arthralgia and facial paralysis was reported as not recovered. Outcome of the event rash was reported as recovered/resolved. Causality of the events were not reported.   Upon internal review, the event facial paralysis was determined to be medically significant.
Age: 15.0
Sex: M
Vaccine: HPV4, UNK
Symptoms: Growth disorder
Clinical narrative: he stopped growing; This spontaneous report was received from a consumer refers to a currently 22-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in July 2012 (reported as 7 years ago), when the patient was approximately 15-year-old, he was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, frequency, route of administration, lot# and expiration date were not reported) for HPV prevention.  On an unknown date (reported as receiving around the same time), the patient started therapy with isotretinoin (ACCUTANE) (frequency, route of administration, strength, dose, lot# and expiration date were not reported) for acne. The reported stated that the therapy with isotretinoin (ACCUTANE) was closely monitored. On an unspecified date, the patient stopped growing. He was predicted to grow to 6 feet 2 inches but reached 5 feet 10 inches. The patient did not received any treatment. Therapy with isotretinoin (ACCUTANE) was discontinued. The reporter considered that the isotretinoin (ACCUTANE) stopped his growth plates and that it has been added to the pamphlet. The reporter also considered that it was not the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as the patient tolerated that with no issues and no rashes. The outcome of the event was not reported.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Malaise, Pain, Product supply issue
Clinical narrative: Product supply issue; fairly sick; joint pain; felt tired / run down; achy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, joint pain, tiredness, pain and product supply issue. On an unknown date, the outcome of the sickness, joint pain, tiredness and pain were recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the sickness, joint pain, tiredness and pain to be related to Shingrix.  Additional information received were as follows: In mid December 2018, the patient received 1st dose of Shingrix. The patient was fairly sick (joint pain and just felt tired, achy) for about 2 days. The patient also experienced joint soreness and felt run down for about 2 days. The patient asked if it would be better or worse after the 2nd dose of Shingrix. The patient got the call to come for the 2nd dosage and they were out of stock when the patient showed up. The patient did not received 2nd dose of Shingrix at the time of reporting , which led to product supply issue. The patient was supposed to get 2nd dose of Shingrix in the afternoon and the clinic the patient used to get the vaccine has been out everytime. The patient was hoping that extra month did not have too big inpact on the effectiveness.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extensive swelling of vaccinated limb, Injection site induration, Injection site pruritus
Clinical narrative: swelling; injection site iching; injection site induration; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date unknown) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Kinrix .5 ml. On 10th July 2019, 2 days after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching and injection site induration were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching and injection site induration to be related to Kinrix.  Additional details were provided as follows: The patient received Kinrix on left arm. The prefilled syringe of Kinrix 1 inch 25 gauge needle was given. The patient's mom noticed swelling on 7 of 10, 4x2 inches swelling, 5x10cm, some induration and itching. The reporter came back to office, no urgent care visit, no fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after 1st dose of Shingrix the patient experienced a sore arm. The reporter did not consent to follow up. The reporter was unable to obtain additional information. For tolerance to the 2nd dose of Shingrix, refer case US2019125910. This case has been linked with case US2019125903, US2019125907, US2019125912,  reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced years ago) and post herpetic neuralgia (postherpetic neuropathy on the left hand side after the prior episode of shingles).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 14 days after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was selected as per the product indication. The patient reported having postherpetic neuropathy type pain on the left hand side after receiving Shingrix 2 weeks prior. The pharmacist reported that there was no rash or anything indicative of shingles, just pain reported by patient. The pharmacist was informed of this reaction from patient's physician, no patient or vaccine information was available to the pharmacist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: fever; achy; fatigued; felt like a very bad flu; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain, fatigue and influenza like illness. On an unknown date, the outcome of the fever, pain and fatigue were resolved with sequelae and the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the fever, pain, fatigue and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving vaccine had a fever and was extremely achy and fatigued. The patient also felt like a very bad flu. The patient did not consent to follow up. This case has been linked with case US2019125909, reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm was sore; fever of 101 F; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were resolved with sequelae.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient received vaccine 2 weeks ago from the time of reporting and experienced pain in arm and had a fever of 101 F. Next day after receiving vaccine the patient experienced fever. The reporter did not consent to follow up. This case has been linked with case US2019125908, reported by the same reporter.      Lab Comments: On an unknown date body temperature was recorded
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 2nd February 2019 and experienced pain in arm).   On 10th July 2019 02:00, the patient received the 2nd dose of Shingrix (intramuscular). On 10th July 2019 07:00, 5 hrs after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: On 10th July 2019, at 2:00 pm, the patient received vaccine and by 7:00 pm that evening noted that her left arm was sore. The patient did not consent to follow up. The reporter was unable to obtain additional information. For tolerance to the 1st dose of Shingrix, refer case US2019AMR130762   This case has been linked with cases US2019125903, US2019125907, US2019125912, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced sore arms after receiving the Shingrix vaccine. The reporter did not consent to follow up. The reporter was unable to obtain additional information. This case has been linked with cases US2019125903, US2019125907, US2019125910, reported by the same reporter.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra vaccine administered; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who was vaccinated with expired vaccine of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number U5948AB (Expiry date 03-Jul-2019) via intramuscular route in the left arm, On 10-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).   It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an adult patient had given the ActHib vaccine today; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 38 years old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI795AA, expiry date: 18-Jun-2022 via unknown route in the right deltoid on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccinations or medications that day.   It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient had been given three doses of Menactra instead of two dose; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site.  The patients past medical history, medical treatments, vaccinations and family history and concomitant therapies were not provided.  It was as actual medication error case due extra dose administered. The patient was administered three doses of Menactra instead of two dose.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Child received DTap-IPV portion (liquid portion) only of ordered Pentacel vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 2 months old patient who received DTap-IPV portion only of ordered vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTap-IPV lot U6137AB; expiry date: 16-Oct-2020; ActHIB lot UJ065AA, expiry date: 16-Oct-2020) via intramuscular route in the right thigh on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation on 12-Jul-2019.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menactra, that reached 33.5 C on july 9; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 17 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019 .  The patient's medical history not reported. Concomitant medication included HPV vaccine.  It was an actual medication error case due to incorrect product storage. It was reported that Menactra reached 33.5C on 09 July 2019.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Pentacel that reached 33.5C; 11 years old patient received pentacel vaccine; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional   This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves an 11 years old patient (gender not reported)who was vaccinated with a 0.5 ml fourth dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ013AAA and Exp. Date 10-OCT-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C  The patient's medical history not reported and concomitant medications not received.  No other vaccine was given that day.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, Product storage error
Clinical narrative: Menactra reached at 33.5C; 16 years old patient received second dose of Menactra; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 16 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant medications not received.  It was an actual medication error case due to extra dose administered and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number of first dose is requested.  List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Quadracel reached 33.5C; 14 years old patient received quadracel; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 14 years old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and Exp. Date 18-Jun-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccine included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunization.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Quadracel reached 33.5C; 14 years old patient received quadracel; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 14 years old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and Exp. Date 18-Jun-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccine included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunization.  It was an actual medication error case due to inappropriate age at vaccine administration and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a nine weeks old patient who was vaccinated with a 0.5 ml first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ014ABA and Exp. Date 26-Oct-2020) via intramuscular route in unknown administration site on 09-Jul-2019.  This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.