chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Rash erythematous
Clinical narrative: Red rash below injection site; Soreness below injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 58-year-old 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 an unknown date).   On 16th June 2019, the patient received the 2nd dose of Shingrix. On 18th June 2019, 2 days after receiving Shingrix, the patient experienced red rash and pain. On an unknown date, the outcome of the red rash and pain were unknown.   It was unknown if the reporter considered the red rash and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash below injection site and soreness below injection site after receiving 2nd dose of Shingrix vaccine.
Age: 58.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Red rash below injection site; Soreness below injection site; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 58-year-old 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 an unknown date).   On 16th June 2019, the patient received the 2nd dose of Shingrix. On 18th June 2019, 2 days after receiving Shingrix, the patient experienced red rash and pain. On an unknown date, the outcome of the red rash and pain were unknown.   It was unknown if the reporter considered the red rash and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash below injection site and soreness below injection site after receiving 2nd dose of Shingrix vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Culture negative, Fatigue, Head discomfort, Influenza like illness
Clinical narrative: feeling tired; nasal drip; being unable to sleep; head congestion; weakness; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th June 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced tiredness, runny nose, sleeplessness, head discomfort and weakness. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the tiredness, runny nose, sleeplessness, head discomfort and weakness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, runny nose, sleeplessness, head discomfort and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and approximately 24 hours following vaccination flu-like symptoms including weakness, feeling tired, nasal drip, and being unable to sleep due to full head congestion. The patient went to his physician's office last Wednesday before the date of reporting and did work ups such as swabs and smears in nose and throat for flu, strep throat, etc. and all was clear.  The patient also reports blood pressure okay, no fever, and having clear lungs.  The patient has another appointment at time of reporting due to symptoms getting worse. The reporter consented to follow up.   Discrepancy regarding to the outcome of the event influenza like illness in document mentioned as recovering and in database given as not recovered/not resolved. so kept as per database.      Lab Comments: lab test were performed on unknown date
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Respiratory tract congestion, Rhinorrhoea, Smear site unspecified normal, Streptococcus test
Clinical narrative: feeling tired; nasal drip; being unable to sleep; head congestion; weakness; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th June 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced tiredness, runny nose, sleeplessness, head discomfort and weakness. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the tiredness, runny nose, sleeplessness, head discomfort and weakness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, runny nose, sleeplessness, head discomfort and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and approximately 24 hours following vaccination flu-like symptoms including weakness, feeling tired, nasal drip, and being unable to sleep due to full head congestion. The patient went to his physician's office last Wednesday before the date of reporting and did work ups such as swabs and smears in nose and throat for flu, strep throat, etc. and all was clear.  The patient also reports blood pressure okay, no fever, and having clear lungs.  The patient has another appointment at time of reporting due to symptoms getting worse. The reporter consented to follow up.   Discrepancy regarding to the outcome of the event influenza like illness in document mentioned as recovering and in database given as not recovered/not resolved. so kept as per database.      Lab Comments: lab test were performed on unknown date
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Nausea; Headache; Pain at injection site; Redness at injection site; Swollen arm; injection site swelling; Shaking; Chills; Fever; This case was reported by a physician via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, 9 hrs after receiving Shingrix, the patient experienced tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the tremor, chills, fever, nausea and headache were recovered/resolved and the outcome of the injection site pain, injection site erythema, swelling arm and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid at 3 PM. About 9 hours later at midnight, the patient experienced shaking, chills, fever above 101 degree F, nausea and headache. The patient also experienced pain, redness, and swollen arm at the deltoid region of the injection site. The fever lasted for 12 hours.  The patient had to take Zofran for her nausea.  The patient had recovered from everything, but she was still experiencing pain, redness and swollen arm, at the time of reporting.  No further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Nausea; Headache; Pain at injection site; Redness at injection site; Swollen arm; injection site swelling; Shaking; Chills; Fever; This case was reported by a physician via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019 15:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, 9 hrs after receiving Shingrix, the patient experienced tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the tremor, chills, fever, nausea and headache were recovered/resolved and the outcome of the injection site pain, injection site erythema, swelling arm and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the tremor, chills, fever, nausea, headache, injection site pain, injection site erythema, swelling arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid at 3 PM. About 9 hours later at midnight, the patient experienced shaking, chills, fever above 101 degree F, nausea and headache. The patient also experienced pain, redness, and swollen arm at the deltoid region of the injection site. The fever lasted for 12 hours.  The patient had to take Zofran for her nausea.  The patient had recovered from everything, but she was still experiencing pain, redness and swollen arm, at the time of reporting.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Injection site pain; Wrong injection technique; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving Shingrix.  The patient felt they did not given it high enough in the deltoid, which led to vaccine administered at inappropriate site.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab, Skin ulcer
Clinical narrative: Scab; shingles; sores; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prostate cancer (at the age of 65 years ).   On 7th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced shingles and skin ulcer. In June 2019, the patient experienced scab. On an unknown date, the outcome of the shingles, skin ulcer and scab were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin ulcer and scab to be related to Shingrix.  Additional case details were provided as follows: About 3 weeks ago from the date of reporting, the patient got shingles for the first time. On 17th June 2019, the patient visited his physician. His sores from the shingles were well scabbed over now and his physician thought he could receive the 2nd dose. The patient said that he worked out. He did not take any major medication. No heart medicine.  The patient did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like Symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on unknown arm. Following 1st dose Shingrix vaccination, the patient experienced flu-like symptoms for 3 days. It was unknown when symptoms began following vaccination. There is a discrepancy with respect to the age group of patient. In source document it was reported as infant while from narrative it is clear that, the patient was adult. Age group captured as per narrative information.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Unknown reaction; This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The patient experienced adverse reaction. Type of reaction to first dose was not reported in request. The reporter does not have additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) (batch number B37G7, expiry date 23rd May 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th June 2019, 2 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist on the chat reporting a patient was experiencing Shingles. The rash was reported and the patient presented to an urgent care where they were diagnosed with shingles and an antiviral was prescribed. No further information was provided. The reporter declined to provide any patient identifiers. The provider who administered the vaccine was the pharmacist on staff using standing orders.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: flu like symptoms; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were unknown.   It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist noted the patient had flu like symptoms consisting of fatigue. The pharmacist did not wish to provide greater detail for patient number as she was busy and in a hurry.  I am reporting what she said with no elaboration. The pharmacist did not wish to provide greater detail for patient number as she was busy and in a hurry.  The reporter gave consent to follow up. This case is linked to case US2019111392, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Feeling cold, Heart rate increased, Nausea, Pain
Clinical narrative: feeling cold; shaking; Pain entire body; nausea; increase in heart rate; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2019, less than a day after receiving Shingrix, the patient experienced feeling cold, tremor, general body pain, nausea and heart rate increased. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the feeling cold, tremor, general body pain, nausea and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feeling cold, tremor, general body pain, nausea and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the day before reporting and developed the following symptoms feeling cold, shaking, pain entire body, nausea, and increase in heart rate.  The patient went to see her physician for the symptoms at the time of reporting and her physician performed an Electrocardiography which was normal.  The reporter consented to follow up. Emergency room visit was required.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: feeling cold; shaking; Pain entire body; nausea; increase in heart rate; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2019, less than a day after receiving Shingrix, the patient experienced feeling cold, tremor, general body pain, nausea and heart rate increased. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the feeling cold, tremor, general body pain, nausea and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feeling cold, tremor, general body pain, nausea and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the day before reporting and developed the following symptoms feeling cold, shaking, pain entire body, nausea, and increase in heart rate.  The patient went to see her physician for the symptoms at the time of reporting and her physician performed an Electrocardiography which was normal.  The reporter consented to follow up. Emergency room visit was required.
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident, Conjunctivitis, Immune system disorder, Meningitis, Seizure
Clinical narrative: Stroke; Meningitis; Suspected vaccination failure; Seizure; Pink Eye; Low immune system; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), stroke (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), pinkeye and immune system disorder. On an unknown date, the outcome of the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder to be related to Meningitis ACWY vaccine (potential Menveo).  Additional information was provided as follows: The age at vaccination was not reported. The patient had received a Meningitis ACWY vaccine (potential Menveo). After vaccination, the patient was hospitalized due to developing Meningitis for 10 days. During hospitalization the patient also had a stroke. About 10 years later now at the time of reporting, the patient was experiencing seizures, and has a low immune system. The patient gets pink eye very often as well. The reporter did not know the exact name of the vaccine that was given to her daughter. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: UNK
Symptoms: Vaccination failure
Clinical narrative: Stroke; Meningitis; Suspected vaccination failure; Seizure; Pink Eye; Low immune system; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), stroke (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), pinkeye and immune system disorder. On an unknown date, the outcome of the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, meningitis, stroke, seizure, pinkeye and immune system disorder to be related to Meningitis ACWY vaccine (potential Menveo).  Additional information was provided as follows: The age at vaccination was not reported. The patient had received a Meningitis ACWY vaccine (potential Menveo). After vaccination, the patient was hospitalized due to developing Meningitis for 10 days. During hospitalization the patient also had a stroke. About 10 years later now at the time of reporting, the patient was experiencing seizures, and has a low immune system. The patient gets pink eye very often as well. The reporter did not know the exact name of the vaccine that was given to her daughter. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: RED; WARM; SORE; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced injection site pain. On 21st June 2019, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: Yesterday, from the date of reporting, the patient experienced soreness at the injection site. On the day of reporting, 2 days after receiving a dose of Shingrix, the area was warm and red. The redness was the size of a quarter. The reporter consented to follow up. There is a discrepancy with respect to the outcome of events injection site erythema and injection site warmth. In source document it was reported as recovering/resolving the from narrative stated the events were not recovered. The outcome captured as per narrative information.
Sex: F
Vaccine: PNC13
Symptoms: Therapeutic response unexpected
Clinical narrative: Her allergist had her receive a Prevnar 13 shot. Her allergies decreased substantially; Her allergist had her receive a Prevnar 13 shot. Her allergies decreased substantially; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization.  Medical history included allergies (sinus).  The patient's concomitant medications were not reported. The patient's allergist had her received the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shot. The patient's allergies decreased substantially on an unspecified date. The outcome of the event was not reported.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: 102.0 fever; This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), 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, it was reported that the patient experienced a 102.0 fever. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date to an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via a Pfizer Sales Representative. This consumer reported similar events for four patients. This is the second of four reports.  A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms days after receiving 1st dose of meningococcal group b rlp2086, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019271974 same reporter, different patient.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported similar events for four patients. This is 3rd of four reports. A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms days after receiving 1st dose of meningococcal group b rlp2086, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019271974 Same reporter, same drug/event, different patient
Sex: U
Vaccine: HPVX, MENB, MNQ, TDAP
Symptoms: Dizziness, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: Flu like symptoms; Sore at injection site; Generalized pain; Swollen arm; Tingling fingers; Headache; Dizziness; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative.   A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) (lot# W62469), via an unspecified route of administration, on an unspecified date, at single dose, for immunization; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunization; hpv vaccine (HPV VACCINE), via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunization; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced flu like symptoms. Symptoms included: headache, sore at injection site, dizziness, and generalized pain. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Pain in extremity, Vitamin B12 decreased, Wheelchair user
Clinical narrative: patient developed weakness -mostly in pelvic area; Neurologist suggests that it may be Guillain Barre; pain in hands, knees and feet; pain in hands, knees and feet; low on B12; This is a spontaneous report from contactable other healthcare professional via Pfizer Sales Representative. A 67-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 28May2019 at single dose for immunization.  The patient's medical history and concomitant medications were not reported. Patient was seen at Primary Care office on 28May2019 and she was vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein). Patient returned to the office on 05Jun2019 with pain in hands, knees and feet. She was admitted to the hospital on 05Jun2019 and remained in the hospital until 07Jun2019. She was told at the hospital she was low on B12 in 2019 and was told to take a supplement. On 08Jun2019 that patient developed weakness -mostly in pelvic area. She returned to the primary care office on 11Jun2019. She came to the office in a wheelchair her weakness was so bad. She was readmitted to the hospital on 11Jun2019 and she is still in the hospital at time of the report. Neurologist suggested that it may be Guillain Barre (2019). The outcome of the events was unknown.; Sender's Comments: Reported events Guillain Barre, weakness and pain in hands, knees and feet more likely represent intercurrent medical conditions unlikely related to the use with the suspected vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: allergy to Prevnar13; This is a spontaneous report from a contactable physician. This physician reported same event for three patients. This is the 1st of 3 reports.  A patient of unspecified age and gender received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumococcal vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. Outcome of the event was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272499 same reporter/drug/event, different patient;US-PFIZER INC-2019272500 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to Prevnar13; This is a spontaneous report received from a contactable physician. This physician reported same event for three patients. This is the 3rd of 3 reports.  A patient of unspecified age and gender received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumococcal vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. Outcome of the event was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272499 same reporter/drug/event, different patient;US-PFIZER INC-2019272471 same reporter/drug/event, different patient
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: 20 patients received Adacel vaccine that had experienced delayed transit time, 11 hours over the recommended transit time, the shipment should have been received on 06-Jun-2019 but it was received on 07-Jun-2019 at 11:52 am; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves 20 patients who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine that had experienced delayed transit time, 11 hours over the recommended transit time, the shipment should have been received on 06-Jun-2019 but it was received on 07-Jun-2019 at 11:52 am lot number and expiry date not reported via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not 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 and Module VI of the 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: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: patient that received the incorrect diluent; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA172536, same reporter.  This case involves a 2 months old male patient who received the incorrect diluent, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant was received.   On 21-Jun-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI973AA, expiry date 04-Apr-2020 via intramuscular route in the left arm.  It was an actual medication error due to Wrong solution used in drug reconstitution.  It was reported that patient that received the incorrect diluent.  It was unknown whether patient experienced any adverse reaction after the injection.  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 and Module VI of the 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: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Rash, Skin warm, Tenderness
Clinical narrative: Vaccination given 6/5/19. On 6/7/19 a large area on the arm developed a rash that was red, warm, & tender. On 6/8/19 patient saw provider at the clinic, and was started on Cephalexin 500mg TID for 7 days. On 6/19/19 all signs of the reactions were gone,
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Rash, Swelling face
Clinical narrative: Patient developed rash on face with swelling.   Injection site was red and tender to touch.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Rash macular
Clinical narrative: splotchy, hard, red section of upper front of arm and side of upper arm
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient came into the pharmacy today and showed me her arm. It had a round, raised, red area around the injection site (about 3 inches in diameter). I felt it and it was very warm. She said that did not happen after the first dose of Shingrix. She did mention she had allergy shots for 4.5 years and had a similar reaction to those. I advised her to watch it and report if it gets worse. Told her she could take benadryl, also told her she could take tylenol/mortin for the pain. She said she would come back if it got worse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: swelling, pain. fever
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Patient said he started to feel tingles around his face within the first 24 hours. Then had a "shingles breakout" on face and head within 48-72 hours after injection. Patient said he had a skull crushing headache 24/7 for about 5 days, and has a stiff neck. He went to see his physician and was prescribed Valtrex.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased
Clinical narrative: Patient states he had no symptoms the evening after the injection given at 3:30pm. He states when he woke about around 7am he was unable to lift or move his arm.  He was at our office by 7:30 am to be evaluated.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 76-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; expired dose of VARIVAX was inadvertenly administered; This spontaneous report was received from a medical assistant referring to a 12-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 18-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, Lot # N014630 expiration date reported as 11-MAY-2019, but upon internal validation established as 11-AUG-2019 (dosage schedule and anatomical location were not reported), for prophylaxis (expired product administered). No adverse effects were reported.  The outcome was reported as supported.
Age: 29.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: she inadvertently administered a dose of MMRII which expired on 12/8/2018; Information has been received from a nurse referring to a 29 years old patient of unknown gender. Information of pertinent medical history and drug reactions/allergies was not reported. The patient had a titers test in November 2018, which came back negative for rubella and measles. Concomitant therapies included sterile diluent.  On 18-JUN-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(lot # M048036, expiration date: 08-DEC-2018, therapy type: rHA, strength, frequency and route were unknown) for prophylaxis (expired vaccine administered). The outcome of the event was unknown.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: his son may have gotten less than a full dose of MMRII; his son may have gotten less than a full dose of MMRII; No adverse effect reported; This spontaneous report has been received from the patient's parent, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient could had vaccinated with a less than full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effect reported.
Sex: M
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: the patient received his first dose of GARDASIL, experienced a reaction two weeks later; received his second dose, and experienced another event shortly after that; This spontaneous report was received from the patient's father and refers to a currently 22 years old male patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported), and experienced a reaction two weeks later (adverse event).         And on an unspecified date, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported), and experienced another event shortly after that (adverse event).      The outcome of adverse event was unknown.  At the time of the report, the causality between the aforementioned events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not provided.
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Cough, Miliaria, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: the patient's symptoms are like adverse reaction; he developed a rash on his back that resembles a "heat rash"; he developed a fever, sore throat and cough; he developed a fever, sore throat and cough; he developed a fever, sore throat and cough; This spontaneous report was received from a registered nurse referring to a 54 year old male patient. The patient did not have pertinent medical history, concomitant medications, drug reactions and allergies.  On 22-APR-2019, the patient was vaccinated with zoster rge vaccine (mammalian)(SHINGRIX) (strength, dose, anatomical location, route of administration, lot#, expiration date, and indication were not reported) and on 08-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, and, route of administration were not reported) lot # R031681 with expiration date on 01-NOV-2020, indicated for prophylaxis.    On 18-JUN-2019, the patient developed a fever (pyrexia), sore throat (oropharyngeal pain) and cough (cough) and started taking over the counter guaifenesin (MUCINEX) and ibuprofen with relief.  On 20-JUN-2019, the patient developed a rash on his back that resembled a "heat rash" (miliaria).   The patient had not been treated by a physician and did not seek medical attention.  Laboratory diagnostics and studies were not performed.   The patient went to the emergency room on 20-JUN-2019, where he was seen by the head of infectious disease with department of public health, and it was determined that the patient's symptoms were like adverse reaction (vaccination complication) to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine but absolutely not an active case of measles. The patient was not admitted to the hospital.   The outcome of pyrexia, vaccination complication, miliaria, cough and oropharyngeal pain was reported as not resolved.     The causal relationship between the events with the suspect therapies was not reported.