chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Injection site pain, Injection site pruritus, Limb discomfort, Lymph node pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain. On an unknown date, the outcome of the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hoursafter vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather vivid dream in which he had developed an egg-sized tender mass at the injection site which he had named Caedlyff, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain. On an unknown date, the outcome of the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hoursafter vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather vivid dream in which he had developed an egg-sized tender mass at the injection site which he had named Caedlyff, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Erythema, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 13th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2018, 1 days after receiving SHINGRIX, the patient experienced erythema (serious criteria disability), dizziness (serious criteria disability) and pain (serious criteria disability). On an unknown date, the outcome of the erythema and pain were not recovered/not resolved and the outcome of the dizziness was recovering/resolving. The reporter considered the erythema, dizziness and pain to be related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX on left arm. The patient experienced redness and soreness of her arm and also dizziness reporting day morning to the point where she felt like she was going to pass out. The patient believed the medication was given subcutaneously instead of intramuscular but the pharmacist noted the documentation was noted as intramuscular. The pharmacist was not the administering pharmacist and planned to speak with the pharmacist. Warm transferred to Medical Information System.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Crying, Headache, Migraine
Clinical narrative: Per child the day she got the two vaccines she went home and around 1:00 PM, she started getting a headache. All of a sudden the pain started getting worse she states it felt more like a Migraine, she ran downstairs to let guardian know. Guardian told us she was scared because the patient was crying non stop that she couldn't tolerate the headache and it was getting worse. Guardian gave child an ibuprofen pill and told her if the pain wouldn't go away they were going straight to the ER. She then states hours later the headache went away and has not experience anything since then.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Myalgia, Pyrexia
Clinical narrative: Day 1: pain on site of injection, lethargy. Day 2: pain on site of injection, all over muscle pain, fever of 102 F. Day 3: pain on site of injection, all over muscle pain, no more fever.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: Complete injection arm paralysis starting the evening of administration 03/12/18. Arm had improving and worsening pain and paralysis for a week after immunization. Patient then went to emergency room to be treated the following Monday. Today 3/21/18 she claims that the arm is improving and she is starting to feel better.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abnormal behaviour, Dysarthria, Impaired driving ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Complete injection arm paralysis starting the evening of administration 03/12/18. Arm had improving and worsening pain and paralysis for a week after immunization. Patient then went to emergency room to be treated the following Monday. Today 3/21/18 she claims that the arm is improving and she is starting to feel better.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Monoplegia, Pain, Pain in extremity
Clinical narrative: Complete injection arm paralysis starting the evening of administration 03/12/18. Arm had improving and worsening pain and paralysis for a week after immunization. Patient then went to emergency room to be treated the following Monday. Today 3/21/18 she claims that the arm is improving and she is starting to feel better.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX. On 11th March 2018, the patient received the 2nd dose of SHINGRIX. In March 2018, several hours after receiving SHINGRIX, the patient experienced fever, pain, difficulty sleeping and muscle pain. On an unknown date, the outcome of the fever, pain, difficulty sleeping and muscle pain were unknown. The reporter considered the fever, pain, difficulty sleeping and muscle pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician who himself was the patient. The patient received SHINGRIX on the left arm. The patient experienced fever, aches, tough time sleeping, and muscular pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Rash, Rash generalised, Rash pruritic, Skin ulcer
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 60-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Levothyroxine, loratadine, omeprazole, Paroxetine and AMBIEN. On 26th January 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced painful rash, skin warm, skin ulcer, itchy rash and generalized rash. The patient was treated with prednisone and BENADRYL (NOS). On an unknown date, the outcome of the painful rash, skin warm, skin ulcer, itchy rash and generalized rash were not recovered/not resolved. The reporter considered the painful rash, skin warm, skin ulcer, itchy rash and generalized rash to be related to SHINGRIX. Additional details were provided as follows: Within a week after receiving SHINGRIX the patient started having symptoms. The patient had a rash that started on her lower side and then spread to her body. The rash was itchy and painful. The patient also developed sores. She had prednisone and it did not help. She had 2 biopsies last week and she did not receive the results back yet. Her rash looked like chicken pox. The patient clarified that it just looks like chicken pox, she had not confirmed that it was chicken pox. She initially thought that it was hives, but prednisone was not helping and it usually does for hives. She also described her rash as starting in an area, and in about 2 week time healing and then moving on to another area. She did not have it on her face and scalp but it looked like it was moving on that direction. She also said that her rash was warm and it helped when she puts cold compresses on top of them. The patient said that she had seen her dermatologist three times since she started having the symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 60-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Levothyroxine, loratadine, omeprazole, Paroxetine and AMBIEN. On 26th January 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced painful rash, skin warm, skin ulcer, itchy rash and generalized rash. The patient was treated with prednisone and BENADRYL (NOS). On an unknown date, the outcome of the painful rash, skin warm, skin ulcer, itchy rash and generalized rash were not recovered/not resolved. The reporter considered the painful rash, skin warm, skin ulcer, itchy rash and generalized rash to be related to SHINGRIX. Additional details were provided as follows: Within a week after receiving SHINGRIX the patient started having symptoms. The patient had a rash that started on her lower side and then spread to her body. The rash was itchy and painful. The patient also developed sores. She had prednisone and it did not help. She had 2 biopsies last week and she did not receive the results back yet. Her rash looked like chicken pox. The patient clarified that it just looks like chicken pox, she had not confirmed that it was chicken pox. She initially thought that it was hives, but prednisone was not helping and it usually does for hives. She also described her rash as starting in an area, and in about 2 week time healing and then moving on to another area. She did not have it on her face and scalp but it looked like it was moving on that direction. She also said that her rash was warm and it helped when she puts cold compresses on top of them. The patient said that she had seen her dermatologist three times since she started having the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (had an outbreak every month). Previously administered products included unknown vaccination (received seven years ago, and started getting outbreaks three years after receiving the shot). On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On 12th March 2018, 38 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not provided. Seven years ago, the patient received the former immunization (Zestar?? from Merck) and started getting outbreaks three years after receiving the shot. In time, the patient had an outbreak every month. The patient received the first of two SHINGRIX shots. Today, the patient had an outbreak. Naturally, the patient was shocked and most disappointed at this. The patient got his immunization to prevent shingles. The patient wanted to have some information of the efficacy of this product. Needless to say, the patient was not impressed so far. So when the SHINGRIX immunization became available, the patient had hopes. The reporter wanted more information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX. 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 fever, chills and injection site rash. On an unknown date, the outcome of the fever, chills and injection site rash were unknown. It was unknown if the reporter considered the fever, chills and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed fever (100 F), rash in the injection site, approximately 2 into 5 inch in size. The rash was not major concern of the patient, chills in conjunction with fever was significant enough, she cancelled all her patients the following day. The event did not cause the patient to be admitted to the hospital overnight. The reporting health care professional did not considered the event to be life threatening. The patient did not die. Nothing was noted other than what was described above. Till the time of reporting the patient did not received 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she was notified via text message from her ex-husband (patient) that a radio personality was on the radio stating that he developed a fever after receiving SHINGRIX this weekend. The call was transferred to collect adverse event. The caller was a pharmaceutical employee. No other information was available to be provided or documented about this call.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX (batch  number 477FS ?, expiry date 30th January 2020, GSK note: the reported lot number did not match with any GSK lot number). Concurrent medical conditions included osteoarthritis. Concomitant products included omeprazole. On 15th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, pain in elbow, skin warm and pain in arm. On an unknown date, the outcome of the erythema, pain in elbow, skin warm and pain in arm were unknown. It was unknown if the reporter considered the erythema, pain in elbow, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient later developed redness, warmth to touch, and pain in her right elbow. This was not at the site of administration. The reporting pharmacist was not aware of any medical intervention taken, but stated that the patient wanted to visit the emergency room and the patient did not want to get the second does.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain and tiredness. In March 2018, the outcome of the injection site pain and tiredness were recovered/resolved. The reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The reporter himself was the patient. The age at vaccination was not reported. The patient experienced pain after starting upon SHINGRIX. No specific details were provided by the reporter about the site of injection or exact dose received. Within a couple of day's receiving after SHINGRIX, the patient had a feeling of tiredness. No further details were provided by the reporter. The reporter did not provide any contact information or demographics except a phone number. The reporter gave permission to be contacted by the phone. It was unknown if the phone number was a personal or pharmacy phone number.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Constipation, Decreased appetite, Faeces hard, Rash generalised
Clinical narrative: Yesterday morning, patient woke up with some abdominal pain. His parents thought that the abdominal pain might be related to constipation since he has a history of this and he also had a couple of hard stools yesterday morning. He has been having a lot of problems with his asthma recently so pulmonology and Dr. wanted him to get the PNEUMOVAX. Patient got this vaccine yesterday morning. After getting the shot, he seemed okay but then started vomiting a couple of hours later. He vomited several times. His parents had already given him some MIRALAX because of the presumed constipation. He then started getting diarrhea. At around 5 PM, Dad noticed some red circles around his face. Slowly, this rash spread into a full body rash. The rash is very itchy. His parents took him to the ED and they monitored him and made sure he was getting BENADRYL. He has been taking BENADRYL every 6-8 hours since the rash began at a dose of 25mg. The BENADRYL does not seem to be helping very much as the rash continued to worsen after they got home from the ED. His appetite is still decreased. He has had no swelling or tingling of the lips or tongue and no shortness of breath. No fever.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Rash pruritic, Vomiting
Clinical narrative: Yesterday morning, patient woke up with some abdominal pain. His parents thought that the abdominal pain might be related to constipation since he has a history of this and he also had a couple of hard stools yesterday morning. He has been having a lot of problems with his asthma recently so pulmonology and Dr. wanted him to get the PNEUMOVAX. Patient got this vaccine yesterday morning. After getting the shot, he seemed okay but then started vomiting a couple of hours later. He vomited several times. His parents had already given him some MIRALAX because of the presumed constipation. He then started getting diarrhea. At around 5 PM, Dad noticed some red circles around his face. Slowly, this rash spread into a full body rash. The rash is very itchy. His parents took him to the ED and they monitored him and made sure he was getting BENADRYL. He has been taking BENADRYL every 6-8 hours since the rash began at a dose of 25mg. The BENADRYL does not seem to be helping very much as the rash continued to worsen after they got home from the ED. His appetite is still decreased. He has had no swelling or tingling of the lips or tongue and no shortness of breath. No fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Confusional state, Emotional distress, Seizure, Syncope
Clinical narrative: Pt had the same reaction as she did on 08/21/17. She fainted almost immediately after being given the HPV 9 and had a small seizure. The Hep A vaccine was given first. She was a little confused and upset when she came to. Pt was given a cool cloth for her forehead and a drink of water. RN enc mom to take child to PCP if she had any concerns or if pt had any other symptoms. RN called mom a few hours later to check in and mom reported that she was fine.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 67-year-old female patient who received SHINGRIX. Concurrent medical conditions included diabetes and penicillin allergy. On 10th March 2018, the patient received the 1st dose of SHINGRIX. On 10th March 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, feeling of warmth and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm, feeling of warmth and pain in arm were recovering/resolving. It was unknown if the reporter considered the erythema of extremities, swelling arm, feeling of warmth and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist stated that the patient received no other vaccines within four weeks prior to receiving SHINGRIX. The reporting pharmacist stated that the patient was currently on insulin and blood pressure medications, but did not know which specific medications at time of call due to being out of facility. The patient received her SHINGRIX in the right deltoid and experienced pain, redness, and warmth on her right arm at the night of administration. The redness was smaller than a baseball on her arm. The reporting pharmacist stated that she was not aware of any medical intervention taken because of patient's reactions. The reporting pharmacist stated she believed the symptoms were related to SHINGRIX. The reporting pharmacist did not have lot number or expiration at time of reporting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 12th March 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, immediately after receiving SHINGRIX, the patient experienced tiredness. On 12th March 2018, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema, tiredness and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, tiredness and injection site pain to be related to SHINGRIX. Additional information was received as follows; The patient received SHINGRIX in the left deltoid. The redness and ache at injection site occurred 30 minutes after vaccination and were about 4 inches in diameter. They were not getting better when the patient reported it 2 days later. No actions were taken by the patient yet.
Sex: U
Vaccine: HEPA, HIBV, HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. Beginning on 08-FEB-2018, the patients were vaccinated with improperly stored GARDASIL 9 lot # N021572, expiry: 01-MAY-2020; N020352, expiry: 10-APR-2020; N009173, expiry: 20-NOV-2019; N014470, expiry: 17-JUN-2019, PEDVAXHIB lot # N014944, expiry: 06-MAR-2020; M046134, expiry: 27-SEP-2019; M014927, expiry 18-FEB-2019, PNEUMOVAX 23 lot # N020688, expiry: 09-MAR-2019; N014946, expiry: 01-FEB-2019; N010106, expiry: 15-NOV-2018, VAQTA lot # N016805, expiry: 04-SEP-2018; N020503, expiry: 04-SEP-2018, ROTATEQ lot # reported as N004810, expiry: 21-OCT-2018; lot number reported as M040606, 28-JUN-2018; M042170, expiry: 22-JUN-2018. The vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 2 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. Lot numbers N004810 and M040606 are invalid lot numbers for rotavirus vaccine, live, oral, pentavalent.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported a 51-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization; methotrexate sodium, ESTROVEN, NORCO, prednisone, albuterol via respiratory inhalation and AMBIEN all via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergies with methotrexate, prednisone, zolpidem tartrate, hydrocodone bitartrate, paracetamol, albuterol, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos and pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The action taken in response to the event for methotrexate sodium, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, hydrocodone bitartrate, paracetamol, prednisone, salbutamol and zolpidem tartrate was unknown. The outcome of the event was unknown. Pfizer is a marketing authorization holder of methotrexate sodium in the reporter's country. This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. The following information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA (lot number requested) 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. On an unspecified date, the patient had soreness, swelling and redness at the injection site. The outcome of the events was unknown. The following information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A 65-year-old female patient of an unspecified race and ethnicity received, on 11Jan2018, pneumococcal 13-val conj vac (dipht crm197 protein) in left deltoid, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient developed a large round swollen area with rash 8 inches across following injection on 11Jan2018. Clinical outcome of the events was unknown at time of this report.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Insomnia, Pain, Screaming, Tachyphrenia
Clinical narrative: Initial unsolicited report received from a patient on 07-Mar-2017. This case involves a 55-year-old male patient who was vaccinated once with 0.5 ml dose of FLUZONE QIV via intramuscular route (batch number: UI829AD; site of administration, expiry date not reported on an unknown date of Dec-2017. The patient's medical history and concomitant medications were not reported. On an unknown date of Dec-2017, immediately after the vaccination, the patient had pain in his whole body that he felt was worsening. On an unknown date, after the vaccination, patient cannot sleep at night and he lies on his couch during the day screaming from the pain he reports racing thoughts, unable to rest at any point. Patient required emergency room visit several times. Laboratory data and corrective treatment was not reported. Patient did not recovered from the events. List of documents held by sender: none.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of numbness in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown. It was unknown if the reporter considered the numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Few days after receiving SHINGRIX, the patient experienced numbness in arm, and left ankle.
Sex: U
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient had a small bump in their arm for approximately 30 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen right deltoid 4" x 4" in size. Warm to the touch.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Vaccine was given intramuscularly, proper route is oral. Patient suffered no adverse reactions.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Mom calls and reports that patient experienced a swollen, hot to touch, 12 cm circle on the right arm. Reports giving patient TYLENOL and Ice on injection site. Mom reports that swollen circle has grown in the last 48 hours. Recommended to contact physician.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Received vaccine in left arm. Injection site became itchy and red approx 12 hours later.
Age: 29.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Extra dose administered
Clinical narrative: Public Health Nurse administered Hepatitis B vaccine in error. Client had completed the 3 dose series.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Patient had recurrent episodes of febrile seizures that occurred on 05/15 and in early June.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Fever, severe muscle pain, severe joint pain.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Abdominal pain, Blood glucose normal, Dysphagia, Eyelid oedema, Hypoaesthesia oral
Clinical narrative: Pt received vaccine approx. 3:45pm. Pt ate "dum dum" pop and snack size bag of potato chips on way home. Pt c/o abd pain and tickle in throat in the car. Once home pt c/o lips felt numb; then mom noticed (L) side of face swelling - called our office at 4:16pm - gave 2tsp BENADRYL 4:30 pt's eyelids were swollen and c/o difficulty swallowing 911 called ? ER.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Laboratory test normal, Swelling face, Throat irritation
Clinical narrative: Pt received vaccine approx. 3:45pm. Pt ate "dum dum" pop and snack size bag of potato chips on way home. Pt c/o abd pain and tickle in throat in the car. Once home pt c/o lips felt numb; then mom noticed (L) side of face swelling - called our office at 4:16pm - gave 2tsp BENADRYL 4:30 pt's eyelids were swollen and c/o difficulty swallowing 911 called ? ER.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Abdominal pain, Blood test, Dysphagia, Eyelid oedema, Hypoaesthesia oral
Clinical narrative: Pt received vaccine approx. 3:45pm. Pt ate "dum dum" pop and snack size bag of potato chips on way home. Pt c/o abd pain and tickle in throat in the car. Once home pt c/o lips felt numb; then mom noticed (L) side of face swelling - called our office at 4:16pm - gave 2tsp BENADRYL 4:30 pt's eyelids were swollen and c/o difficulty swallowing 911 called ? ER.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Injection site swelling, Swelling face, Throat irritation
Clinical narrative: Pt received vaccine approx. 3:45pm. Pt ate "dum dum" pop and snack size bag of potato chips on way home. Pt c/o abd pain and tickle in throat in the car. Once home pt c/o lips felt numb; then mom noticed (L) side of face swelling - called our office at 4:16pm - gave 2tsp BENADRYL 4:30 pt's eyelids were swollen and c/o difficulty swallowing 911 called ? ER.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Oedema peripheral, Rash, Rash pruritic
Clinical narrative: Pruritic rash arms, abdomen and legs Lt hand erythematous and edematous. Tx: Methylprednisolone 4mg oral table therapy pack.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Screaming
Clinical narrative: Child went to school after appointment, returned home around 3 pm. Took a nap until 5-530 pm. Woke up screaming his thigh hurt, didn't want to walk. Father states was "a little red and little swollen". Ice applied and rest. At bedtime child had no complaints. On 3/21/18 he C/O thigh hurting and was swollen. Took to ER - DECADRON given. Advised to use MOTRIN and ice. As of 1 pm - Father states he's walking and no complaints.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient had multiple lesions on left shoulder, trunk, and buttocks.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema
Clinical narrative: Patient's father stated that the patient started to have flat red spot on her face, and forehead. Patient did not experience any shortness of breath. Patient's father was asked to call 911 due to the father having transportation issues. Patient's father stated that he contacted 911 and the ambulance came out and did not recommend for the patient to be taken to the hospital at that time. On the morning of 03/21/2018 patients father was contacted and an update was given that the patient had improved and he has no further concerns at this time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Myalgia, Pyrexia
Clinical narrative: FEVER OF 99.9. STOMACH ACHE. MUSCLE ACHES.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient states the next morning after the injection date of 01/05/2018, she states she was having extreme difficulty lifting or rotating left arm with tolerable soreness. Pt had just informed me on Thursday 03/15/2018 and that she had reported to her doctor and the doctor indicated that may be related to vaccine which could cause shoulder injury. Since 03/15/18, she is currently undergoing physical therapy with the shoulder and deltoid strapped down. Pt's states that there has been improvements since she started the physical therapy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Client reported to Clinic around 10:00 AM 3/21/2018. Significant swelling redness and warmth at the injection site and below down to 5 inches below elbow joint. Client reports no other symptoms. Educated patient PCP to rule out cellulitis. Patient does not have PCP referred her to NP. Requested patient to contact Health Department with further questions and after she is seen by NP. Patient may wait until tomorrow to see NP despite being encouraged to call today.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Client reported to Clinic around 10:00 AM 3/21/2018. Significant swelling redness and warmth at the injection site and below down to 5 inches below elbow joint. Client reports no other symptoms. Educated patient PCP to rule out cellulitis. Patient does not have PCP referred her to NP. Requested patient to contact Health Department with further questions and after she is seen by NP. Patient may wait until tomorrow to see NP despite being encouraged to call today.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 44.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported on 3/12/18 that (R) arm starting hurting with redness and swelling stated it started at night of 3/9/18. Area assessed by RN and referred to urgent care.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Bacterial test, Conjunctival ulcer, Conjunctivitis, Laboratory test normal
Clinical narrative: 4 hours after immunization patient developed bilateral conjunctivitis that was fairly severe and accompanied with conjunctival ulceration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Mother called health center and stated R arm swollen, hot, red with streaks going down arm - referred to ER or pediatricians office.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness, fatigue, chills, myalgia and arthralgia.
Sex: U
Vaccine: MMR, MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an immunization official refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 01-MAY-2017 to 31-JAN-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # N004817, Expiry date: 06-OCT-2018, Lot # N010706, Expiry date: 02-DEC-2018, Lot # N011647, Expiry date: 17-NOV-2018, Lot # M040268, Expiry date: 14-MAY-2018, Lot # M041765, Expiry date: 05-MAY-2018, Lot # M041768, Expiry date: 25-JUN-2018, Lot # M045546, Expiry date: 12-JUN-2018, Lot # M046000, Expiry date: 27-JUN-2018, Lot # N004817, Expiry date: 06-OCT-2018, Lot # N010706, Expiry date : 02-DEC-2018, Lot # N010707, Expiry date: 03-DEC-2018, Lot # N011647, Expiry date: 17-NOV-2018), M-M-R II recombinant human albumin (rHA) (Lot # L039613, Expiry date: 08-OCT-2017, Lot # M032487, Expiry date: 05-JUL-2018, Invalid Lot # M019233, Expiry date: 17-OCT-2017, Lot # M032487, Expiry date: 05-JUL-2018, Lot # M040558, Expiry date: 30-OCT-2018, Invalid Lot # M042497, Expiry date: 17-APR-2018, Lot # M042498, Expiry date: 17-APR-2018, Lot # M045101, Expiry date: 20-NOV-2018, Lot # M045402, Expiry date: 14-NOV-2018, Invalid Lot # M046368, Expiry date: 27-MAY-2018, Lot # M045402, Expiry date: 14-NOV-2018, Lot # N008366, Expiry date: 13-MAR-2019), PROQUAD (Lot # M046368, Expiry date: 27-MAY-2018, Lot # N002325, Expiry date: 19-JUL-2018, Lot # N010865, Expiry date: 01-OCT-2018, Lot # N014949, Expiry date: 11-NOV-2018, Lot # N019250, Expiry date: 20-DEC-2018, Lot # N020012, Expiry date: 13-JAN-2019, Lot # N021726, Expiry date: 06-FEB-2019) and VARIVAX (Lot # M005972, Expiry date: 02-FEB-2018, Lot # M010484, Expiry date: 01-MAR-2018, Lot # M025870, Expiry date: 24-MAY-2018, Lot # M039318, Expiry date: 20-SEP-2018, Lot # M041079, Expiry date: 06-OCT-2018, Lot # N014632, Expiry date: 11-MAY-2019) for prophylaxis. It was reported that M-M-R II and ROTATEQ vaccines experienced a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 509 Hours 30 minutes, PROQUAD and VARIVAX vaccines experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 112 Hours 36 minutes. There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this call was reported due to a digital data logger. Follow up information has been received from the physician on 08-MAR-2018. The following lot numbers M046368, M042497 and M019233 were deleted from M-M-R II as it was confirmed that they belong to in the PROQUAD vaccine.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unspecified age and gender. The patient's concomitant medication, pertinent medical history, drug reactions and allergies information was not provided. The physician reported that, on 26-FEB-2018, the patient was vaccinated with the M-M-R II lot number M045390 and expiration date 14-NOV-2018; subcutaneously, in the right upper arm, for prophylaxis. It was also reported that the M-M-R II was reconstituted with 0.4% sodium chloride (manufacturer unknown) lot number U5858BA and expiration date 28-JUN-2018. The physician reported that no adverse effects were experienced by the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal stiffness, Pain, Polymyalgia rheumatica
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-OCT-2011, the patient was vaccinated at a  pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but caused the patient to contact a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, he developed severe pain and stiffness throughout his body. The patient presented to his primary care physician and was diagnosed as suffering from polymyalgia rheumatic. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Polymyalgia rheumatic, persistent strain of herpes zoster and vaccine did not prevent shingles was considered disabling. Upon internal review, polymyalgia rheumatic was determined to be medically significant. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Headache, Injection site erythema, Pain
Clinical narrative: Redness, inflammation, pain, hard lump on vaccine spot. Body soreness and headache. Multiple red blisters (about 30) all over body (head, face, arms, legs, chest, abdomen).
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site induration, Vaccination site inflammation, Vaccination site mass, Vaccination site pain
Clinical narrative: Redness, inflammation, pain, hard lump on vaccine spot. Body soreness and headache. Multiple red blisters (about 30) all over body (head, face, arms, legs, chest, abdomen).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling cold, Malaise, Pyrexia
Clinical narrative: I had a fever the day after HPV shot; feeling cold; I feel better today but still sick.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Mild to moderate hives without involvement of oral mucosa or respiratory sx. Non-systemic; follows joints. Hives appeared first to left elbow, followed by knees, ankles, wrist, and finger joints bilaterally. Onset approximately within 4 hours of injection. Resolving by following day. Patient self-administered OTC BENADRYL evening of 3/20/18.  Patient with no hx of vaccine reactions in the past-- she has received all routine childhood vaccines.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Per mother's report, child began to exhibit a red, pinpoint rash on abdomen on 3/14/18, which then spread to whole abdomen, back and head. Child also had local redness and swelling on left thigh that started on 3/11/18, which has persisted - but is within a normal expected reaction. Child was evaluated on 3/21/18 at the ER - with the diagnosis of viral rash and cellulitis of left leg. Child was prescribed Cephalexin 250 mg/5 ml suspension - 4.6 ml PO twice daily for 10 days, Mupirocin 2% ointment three times daily, thin layer on thigh redness. Mother also reported a low grade fever and general less appetite for the child in the past few days, which she believes is related to tooth eruption. Mother was told to be seen in 5 days if for a follow-up visit at the medical home.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Teething, Viral rash
Clinical narrative: Per mother's report, child began to exhibit a red, pinpoint rash on abdomen on 3/14/18, which then spread to whole abdomen, back and head. Child also had local redness and swelling on left thigh that started on 3/11/18, which has persisted - but is within a normal expected reaction. Child was evaluated on 3/21/18 at the ER - with the diagnosis of viral rash and cellulitis of left leg. Child was prescribed Cephalexin 250 mg/5 ml suspension - 4.6 ml PO twice daily for 10 days, Mupirocin 2% ointment three times daily, thin layer on thigh redness. Mother also reported a low grade fever and general less appetite for the child in the past few days, which she believes is related to tooth eruption. Mother was told to be seen in 5 days if for a follow-up visit at the medical home.