chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Pnenomax 23 vaccine on 8/28/2020. The expiration date on consent form said 8/2021. After giving pt the vaccine, I saw expiration date on actual syringes to be 8/12/2020. The patient stayed in store for approximately 30 mins to make sure he was ok. He was immediately informed and felt no adverse effects. I immediately called the manufacturer (Merck) on 8/28/2020. The manufacturer said that there were no recommendations for the patient to get evaluated by a healthcare provider. They recommend that I just wait until Monday for them to call me back to let me know if the patient should be revaccinated or not. They informed me that the patient is not in any immediate harm. On 8/29/2020, I called the patient to make sure he was ok. He stated he was fine and that he did not have any adverse effects. On 8/31/2020, Merck called us back and informed me that the vaccine was still potent enough because the manufacturer guarantees stability of it for approximately/month past the written expiration date. The vaccine was potent enough for the patient based on this information.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea
Clinical narrative: & chills, diarrhea,arm pain
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: SkinRash, Rash & Rash
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Impaired work ability, Pain in extremity
Clinical narrative: Patient received IM Shingrix vaccine 3/2/20 in L arm. On 3/4/20 patient spoke with MD on phone, reported on 3/2/30 arm was very sore, 3/3/20 experienced severe fatigue/joint pain and had to leave work to rest. MD discussed risk/benefit of receiving second dose, patient elected to receive second dose. Patient received second dose 8/3/20, no indication of another ADR.
Sex: F
Vaccine: IPV, IPV
Symptoms: Wrong product administered
Clinical narrative: Pt. was administer 0.1 ml of what was assumed was Aplisol TB vaccine, but realized after inj. that it was the polio vaccine, which had been stored in refrigerator where Aplisol is stored, not polio. Per manufacturer, ACIP states No reported risks exist R/T this
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Erythema, Fatigue, Myalgia
Clinical narrative: Patient started to have severe tremors which then caused muscle aches. She couldn't sleep so she got up to read and then suddenly vomited. In the morning she was left with a deep cough, dizziness, and fatigue. Also has local redness and itching.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Tremor, Vomiting
Clinical narrative: Patient started to have severe tremors which then caused muscle aches. She couldn't sleep so she got up to read and then suddenly vomited. In the morning she was left with a deep cough, dizziness, and fatigue. Also has local redness and itching.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Tinnitus
Clinical narrative: Patient experienced ringing in ears
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Hypoaesthesia, Loss of consciousness, Muscle tightness
Clinical narrative: seizure occurred; briefly stopped breathing; He is shaken up; still a little scared; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SN5B, expiry date 4th December 2020) for prophylaxis.   On 17th August 2020 09:20, the patient received Boostrix. In August 2020, less than a week after receiving Boostrix, the patient experienced agitation and fear. On 17th August 2020, the patient experienced apnea (serious criteria GSK medically significant). On 17th August 2020 09:35, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and apnea were recovered/resolved and the outcome of the agitation and fear were unknown.   It was unknown if the reporter considered the seizure, apnea, agitation and fear to be related to Boostrix.  Additional details were reported as follows: The patient received the Shingrix on 17th August 2020 at 9:20 am and at 9:35 am the seizure occurred.   The patient was transported and treated at the ER.  A CT Scan was done. The had briefly stopped breathing and he was shaken up and a little scared. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Respiratory arrest, Resuscitation, Seizure, Urinary incontinence, Vision blurred
Clinical narrative: seizure occurred; briefly stopped breathing; He is shaken up; still a little scared; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SN5B, expiry date 4th December 2020) for prophylaxis.   On 17th August 2020 09:20, the patient received Boostrix. In August 2020, less than a week after receiving Boostrix, the patient experienced agitation and fear. On 17th August 2020, the patient experienced apnea (serious criteria GSK medically significant). On 17th August 2020 09:35, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and apnea were recovered/resolved and the outcome of the agitation and fear were unknown.   It was unknown if the reporter considered the seizure, apnea, agitation and fear to be related to Boostrix.  Additional details were reported as follows: The patient received the Shingrix on 17th August 2020 at 9:20 am and at 9:35 am the seizure occurred.   The patient was transported and treated at the ER.  A CT Scan was done. The had briefly stopped breathing and he was shaken up and a little scared. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Agitation, Apnoea, Computerised tomogram, Fear, Seizure
Clinical narrative: seizure occurred; briefly stopped breathing; He is shaken up; still a little scared; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SN5B, expiry date 4th December 2020) for prophylaxis.   On 17th August 2020 09:20, the patient received Boostrix. In August 2020, less than a week after receiving Boostrix, the patient experienced agitation and fear. On 17th August 2020, the patient experienced apnea (serious criteria GSK medically significant). On 17th August 2020 09:35, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and apnea were recovered/resolved and the outcome of the agitation and fear were unknown.   It was unknown if the reporter considered the seizure, apnea, agitation and fear to be related to Boostrix.  Additional details were reported as follows: The patient received the Shingrix on 17th August 2020 at 9:20 am and at 9:35 am the seizure occurred.   The patient was transported and treated at the ER.  A CT Scan was done. The had briefly stopped breathing and he was shaken up and a little scared. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia
Clinical narrative: Pain at injection site / throbbing so bad this time; Persistent joint pain in both ankles, elbows hands and shoulders/Her knees are weak; Knees are weak; Throbbing pain; Extreme nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cipro with an associated reaction of hypoaesthesia (in 2001 Cipro made both of her arms numbness.). Concurrent medical conditions included hypersensitivity and arthritis.   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, joint pain, lower extremities weakness of and throbbing pain were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experince pain at injection site it was throbbing so bad and also had dizziness and extreme nausea for 2-3 days.  The patient had persistent joint pain in both ankles, elbows hands and shoulders and her knees are weak. The reporter consented to follow up. For tolerance of 1st dose refer case US2020AMR138759.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR138759:same patient, 1st dose
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Injection site pain, Muscular weakness, Nausea
Clinical narrative: Pain at injection site / throbbing so bad this time; Persistent joint pain in both ankles, elbows hands and shoulders/Her knees are weak; Knees are weak; Throbbing pain; Extreme nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cipro with an associated reaction of hypoaesthesia (in 2001 Cipro made both of her arms numbness.). Concurrent medical conditions included hypersensitivity and arthritis.   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, joint pain, lower extremities weakness of and throbbing pain were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experince pain at injection site it was throbbing so bad and also had dizziness and extreme nausea for 2-3 days.  The patient had persistent joint pain in both ankles, elbows hands and shoulders and her knees are weak. The reporter consented to follow up. For tolerance of 1st dose refer case US2020AMR138759.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR138759:same patient, 1st dose
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Pain at injection site / throbbing so bad this time; Persistent joint pain in both ankles, elbows hands and shoulders/Her knees are weak; Knees are weak; Throbbing pain; Extreme nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cipro with an associated reaction of hypoaesthesia (in 2001 Cipro made both of her arms numbness.). Concurrent medical conditions included hypersensitivity and arthritis.   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, joint pain, lower extremities weakness of and throbbing pain were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea, dizziness, joint pain, lower extremities weakness of and throbbing pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experince pain at injection site it was throbbing so bad and also had dizziness and extreme nausea for 2-3 days.  The patient had persistent joint pain in both ankles, elbows hands and shoulders and her knees are weak. The reporter consented to follow up. For tolerance of 1st dose refer case US2020AMR138759.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR138759:same patient, 1st dose
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Urticaria
Clinical narrative: Hives rash; Fatigue; Swelling at the injection site; Redness and swelling at the injection site; Pain, redness and swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2020, 1 days after receiving Shingrix, the patient experienced hives and fatigue. In August 2020, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the hives, injection site swelling, injection site erythema, injection site pain and fatigue were unknown.   It was unknown if the reporter considered the hives, injection site swelling, injection site erythema, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient reported pain, redness and swelling at the injection site.  The patient also reported fatigue and a hives rash on her leg the day after the vaccination.  No consent to follow-up with doctor. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Hives rash; Fatigue; Swelling at the injection site; Redness and swelling at the injection site; Pain, redness and swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2020, 1 days after receiving Shingrix, the patient experienced hives and fatigue. In August 2020, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the hives, injection site swelling, injection site erythema, injection site pain and fatigue were unknown.   It was unknown if the reporter considered the hives, injection site swelling, injection site erythema, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient reported pain, redness and swelling at the injection site.  The patient also reported fatigue and a hives rash on her leg the day after the vaccination.  No consent to follow-up with doctor. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives rash; Fatigue; Swelling at the injection site; Redness and swelling at the injection site; Pain, redness and swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2020, 1 days after receiving Shingrix, the patient experienced hives and fatigue. In August 2020, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the hives, injection site swelling, injection site erythema, injection site pain and fatigue were unknown.   It was unknown if the reporter considered the hives, injection site swelling, injection site erythema, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient reported pain, redness and swelling at the injection site.  The patient also reported fatigue and a hives rash on her leg the day after the vaccination.  No consent to follow-up with doctor. The reporter did not consent to follow up.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Asthenopia, Blood test, Chest X-ray, Fatigue
Clinical narrative: Severe fatigue, severe muscle aches, headache, eye strain, shooting nerve pain, problems processing thoughts, weakness.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Myalgia, Neuralgia, Pain, Thinking abnormal
Clinical narrative: Severe fatigue, severe muscle aches, headache, eye strain, shooting nerve pain, problems processing thoughts, weakness.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: caller reported administered MMR II that was improperly sotred; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA))(M-M-R II) lot # S020161, expiration date 30-JUN-2021 (dose and route of administration were not reported), for prophylaxis. Administered dose of the suspect vaccine experienced the temperature excursion of 10F. There was previous temperature excursions reported. The administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) experienced temperature excursion below 36 Fahrenheit degrees (10F) for 50 minutes. The digital data logger was involved to capture the temperature excursion.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA001689: US-009507513-2008USA001787:
Sex: F
Vaccine: PPV
Symptoms: Borrelia test negative, Diarrhoea, Fatigue, Hyperthermia, Impaired work ability
Clinical narrative: diarrhea; feeling fatigued; fevers / fevers were 100.9; feels sick / very sick; temperature consistently around 99.4 and 99.2 / technically not a true fever; This spontaneous report was received from a female patient of unknown age who was a veterinarian. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, anatomical location, lot# and expiration date not reported) intramuscularly (IM) for prophylaxis.  The patient was "OK" for the 3 days following the vaccination, but then on 02-AUG-2020, the patient was felling fatigued and ended up having diarrhea (diarrhoea) and fevers (pyrexia). Her temperature was 100.9 (units not reported) for 4 days. On an unspecified date in August 2020 (reported as now), the patient's body temperature was 99.4 (units not reported) and 99.2 (units not reported) and she reported that she knew that it was technically not a fever but it was for her (hyperthermia) and that she felt sick all the time (malaise) and could not work. She stated that these events were affecting her life and had to figure this out. The patient sought medical attention and notified her health care professional (HCP) who performed some test like a fecal exam (unspecified), a metabolic profile and a test for Lyme disease, all these tests were negative. The HCP refused to test the patient for coronavirus disease 2019 (COVID-19) due certainty that the patient did not have it; however, the patient had a nasal swab for COVD-19 at a pharmacy which came back negative. At the time of the report, the patient had not recovered from the events. She felt worse than before, on an unspecified date in August 2020, she was feeling better for a couple of days, but unfortunately, she felt that she was rebounding back to being very sick. Her HCP was aware of how she felt at the time of the report. No treatment was given for the events.  The causal relationship of fatigue, diarrhea, pyrexia, hyperthermia and malaise with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Metabolic function test normal, Pyrexia, SARS-CoV-2 test negative, Stool analysis normal
Clinical narrative: diarrhea; feeling fatigued; fevers / fevers were 100.9; feels sick / very sick; temperature consistently around 99.4 and 99.2 / technically not a true fever; This spontaneous report was received from a female patient of unknown age who was a veterinarian. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, anatomical location, lot# and expiration date not reported) intramuscularly (IM) for prophylaxis.  The patient was "OK" for the 3 days following the vaccination, but then on 02-AUG-2020, the patient was felling fatigued and ended up having diarrhea (diarrhoea) and fevers (pyrexia). Her temperature was 100.9 (units not reported) for 4 days. On an unspecified date in August 2020 (reported as now), the patient's body temperature was 99.4 (units not reported) and 99.2 (units not reported) and she reported that she knew that it was technically not a fever but it was for her (hyperthermia) and that she felt sick all the time (malaise) and could not work. She stated that these events were affecting her life and had to figure this out. The patient sought medical attention and notified her health care professional (HCP) who performed some test like a fecal exam (unspecified), a metabolic profile and a test for Lyme disease, all these tests were negative. The HCP refused to test the patient for coronavirus disease 2019 (COVID-19) due certainty that the patient did not have it; however, the patient had a nasal swab for COVD-19 at a pharmacy which came back negative. At the time of the report, the patient had not recovered from the events. She felt worse than before, on an unspecified date in August 2020, she was feeling better for a couple of days, but unfortunately, she felt that she was rebounding back to being very sick. Her HCP was aware of how she felt at the time of the report. No treatment was given for the events.  The causal relationship of fatigue, diarrhea, pyrexia, hyperthermia and malaise with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; chills; fever; This spontaneous report was received from a pharmacist referring to a 79 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 19-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route, lot number and expiration date were not reported) in an unknown arm for prophylaxis.      On the morning of 21-AUG-2020, the patient experienced chills, body aches and a fever. The fever had been as high as 101 degrees Fahrenheit. The pharmacist reported that the patient took acetaminophen (TYLENOL) a few hours ago but the fever had only gone down to 99 degrees Fahrenheit. The pharmacist was trying to rule out coronavirus disease (COVID) symptoms. The outcome of all events was unknown. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; Nurse called to report a patient received improperly stored ROTATEQ on 8/11/2020.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 11-AUG-2020, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (described as "vial 2") orally, for prophylaxis (strength, dose and, vaccination scheme were not reported; lot number 1660981, expiration date 13-APR-2021, which were verified to be valid) (product storage error). The vaccine was stored at a temperature above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (8.9 C) for 33 minutes, as recorded by the data logger. No previous temperature excursion was reported. No additional events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 24-MAR-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: On 13-AUG-2020 a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a Licensed Practical Nurse and refers to a 9-months-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history, drug reactions/allergies and historical drugs was not provided.  On 13-AUG-2020, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) (dosage regimen was not reported) intramuscular, lot #S036823 and expiration date 31-MAR-2022 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion above 47 degrees Fahrenheit (°F)/9 degrees Celsius (°C), 8.9°C for 33 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient's physician administers PNEUMOV AX 23 every 8 years to the patient, because the patient has asthma; This spontaneous report was received from a pharmacist concerning a female patient of an unknown age    The patient's concurrent conditions included asthma. The patient's medical history and concomitant medication were not provided.        On an unspecified date, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis.      The pharmacist stated that the patient's physician administered Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) to the patient, because the patient had asthma. The last date of administration of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was 08-NOV-2012.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 11-MAy-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction, Product use in unapproved indication
Clinical narrative: she bad a really bad reaction/ Reaction was intimidate; The patient had heard that it fights against Covid/ that patient requested it after her daughter told her it would help fight against COVID; This spontaneous report has been received from a nurse, referring to a 57 years old female patient. The patient's pertinent medical history included palpitations and anxiety disorder. The patient's drug reactions or allergies included lidocaine, latex (some redness), tramadol, sertraline hydrochloride (ZOLOFT), acetaminophen (+) hydrocodone bitartrate (VICODIN) and tropicamide. The patient's concomitant medication was unknown by reporter.  On 20-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S031483 with expiration date: 07-OCT-2021; 0.5 milliliter, strength unknown), subcutaneously for prophylaxis (reported as fight against corona virus disease 2019 (COVID)) (product use in unapproved indication).        On the same day, the patient had a really bad reaction and went to the emergency room (ER). Reaction was intimidate. The patient left the emergency department after waiting and before being treated. The patient was given treatment with oxygen for this event. It was unknown if lab diagnostics or studies performed or not. The outcome of bad reaction was unknown (also reported as present status: stable). The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and bad reaction was related.   The reporter considered the bad reaction to be serious for the following reason: significant disability or incapacity.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Taste disorder
Clinical narrative: the patient developed pain, swelling, and redness around injection site; the patient developed pain, swelling, and redness around injection site; the pain developed pain, swelling, and redness around injection site; altered taste and "food did not taste right"; This spontaneous report has been received from a pharmacist, concerning a 60-year-old female patient. The patient's concurrent conditions included drug allergy to sulfa and penicillin; furthermore, a minor egg allergy. Historical conditions and concomitant medications were not provided.      On 26-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date not reported, but upon internal validation established as 06-MAR-2021 (dose, frequency, route and anatomical location were not provided) for prevention of pneumonia.    On 26-AUG-2020, the patient experienced pain, swelling and redness around injection site; furthermore, on the same date, the patient experienced altered taste and "food did not taste right" (taste disorder). The patient did not seek medical attention and did not received any treatment.  The outcome of injection site pain, taste disorder, injection site erythema and injection site swelling was reported as not resolved.  The reporter did not provide a causal relationship between the adverse events and the therapy.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S013490; expirationdate: 06-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received her initial dose of VARN AX 6 daysprior to her 1st birthday.; no adverse event; This spontaneous report was received from a medical assistant and refers to an 11 month old female patient, that at the time of this report was 16 years old. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.      On an unknown date (reported as " 6 days prior to her 1st birthday"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 1st dose of Shingrix and broke out.; This case was reported by a consumer via interactive digital media and described the occurrence of skin breakout 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 skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout 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 selected as per the vaccine indication. The patient received the dose of Shingrix and broke out.
Sex: F
Vaccine: HPV2
Symptoms: Pain
Clinical narrative: acute pain; This case was reported by a other health professional via other manufacturer and described the occurrence of pain in a 45-year-old female patient who received HPV 16-18 (Cervarix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Cervarix. On an unknown date, unknown after receiving Cervarix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Cervarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed acute pain following a 3rd injection of Cervarix, the prophylactic human papillomavirus 16 per 18 vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: arm sore; nausea; chills; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included niraparib (Zejula).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting Zejula, the patient experienced pain in arm, nausea and chills. On an unknown date, the outcome of the pain in arm, nausea and chills were unknown.   It was unknown if the reporter considered the pain in arm, nausea and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The shingles vaccine made her arm sore, nausea and chills. This case has been linked with case US2019TSO237002 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Vision problems; This case was reported by a pharmacist via interactive digital media and described the occurrence of abnormal vision 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, 24 hrs after receiving Shingrix, the patient experienced abnormal vision. On an unknown date, the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the abnormal vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed vision problems about 24 hours after receiving his 1st dose of Shingrix. The patient asked is there a possibility the two are connected since the vaccine is the only thing that was different in his daily routine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Pain, Rash vesicular
Clinical narrative: pain starting on her lower back and progressed to her left side; rash with clear blisters; pain starting on her lower back; pain progressed to her left side and stomach; This case was reported by a consumer via call center representative and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 3 days after receiving Shingrix, the patient experienced pain, blistery rash, back pain and stomach pain. On an unknown date, the outcome of the pain and blistery rash were not recovered/not resolved and the outcome of the back pain and stomach pain were unknown.   It was unknown if the reporter considered the pain, blistery rash, back pain and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced approximately 3 to 4 days after the injection noticed a rash with clear blisters and pain starting on her lower back and progressed to her left side and stomach.  The reporter did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was out of range temperature and no good for be use.; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 21st November 2021) for prophylaxis.   On 25th August 2020, the patient received Boostrix. On 25th August 2020, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The vaccine was stored out of range temperature and no good for be use.  No adverse event was reported. The reporter consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: large, swollen arm; This case was reported by a other health professional via sales rep and described the occurrence of large arm swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced large arm swelling. On an unknown date, the outcome of the large arm swelling was unknown.   It was unknown if the reporter considered the large arm swelling to be related to Bexsero.  Additional details were provided as follows: The patient had large swollen arm after receiving the Bexsero vaccination.  No additional details were available. The reporter consent to follow up.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient received expired vaccine, no AE; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from other healthcare professional .  This case involves a four-month-old female patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number not reported, expiry date 12-Aug-2020) (expired product administered) via an unknown route in an unknown administration site on an unknown date for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  Lab data, corrective treatment and outcome: not applicable.  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 . 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.  There will be no information on the batch number for this case.
Age: 33.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Ipol was inadvertently administered instead of tubersol/no AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional..  This case involves a 33 years old male patient who was inadvertently vaccinated with 0.1 mL IPV (VERO) [IPOL] (batch number P1F54 and expiry date 07-Dec-2020) via intradermal route in the left arm on 26-Aug-2020 for prophylactic vaccination instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test (wrong product administered).  Medical history, concomitant therapy,  medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: low grade fever for two days    Indurated and erythematous  on entire upper left arm for 4 plus days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Headache, Pain in extremity
Clinical narrative: The vaccine was performed early Wednesday morning.  The rest of the day the left arm was very sore. On Thursday morning after the vaccine, had a severe headache, a little upset stomach and a temperature of close to 100 degrees. Took an Aleve and slept another 4 to 5 hours.  The headache was less severe and took my temperature and it was close to normal. Did not eat much that evening but felt better on Friday.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: thigh swelling, cellulitis
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: He woke up during the night with a 104 degree temp and began to vomit. The high fever and vomiting continued for around 24 hours. He was given Tylenol but even with that his fever would only get to around 102 degrees.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Dizziness, Fatigue, Feeding disorder, Headache
Clinical narrative: In the order of occurrence: Day 0: sensitive skin on lower back. Insomnia and restlessness. Day 1: Sensitive skin everywhere. Headache. Extremely tired, spent most of the day in bed. Fast heartbeat and awareness of hearbeat. Muscle pain in back. Joint pain in knuckles, knees, ankles. Fever 100 in the morning, 98 in the evening. Slight nausea, would not eat. Really dizzy. Pain in throat, slight swelling. Days 2 & 3: all gone except insomnia and some tiredness. Day 4: Tired because of insomnia; knuckle pain in left hand. This is the day of this report.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Heart rate increased, Insomnia, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: In the order of occurrence: Day 0: sensitive skin on lower back. Insomnia and restlessness. Day 1: Sensitive skin everywhere. Headache. Extremely tired, spent most of the day in bed. Fast heartbeat and awareness of hearbeat. Muscle pain in back. Joint pain in knuckles, knees, ankles. Fever 100 in the morning, 98 in the evening. Slight nausea, would not eat. Really dizzy. Pain in throat, slight swelling. Days 2 & 3: all gone except insomnia and some tiredness. Day 4: Tired because of insomnia; knuckle pain in left hand. This is the day of this report.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Restlessness, Sensitive skin, Swelling
Clinical narrative: In the order of occurrence: Day 0: sensitive skin on lower back. Insomnia and restlessness. Day 1: Sensitive skin everywhere. Headache. Extremely tired, spent most of the day in bed. Fast heartbeat and awareness of hearbeat. Muscle pain in back. Joint pain in knuckles, knees, ankles. Fever 100 in the morning, 98 in the evening. Slight nausea, would not eat. Really dizzy. Pain in throat, slight swelling. Days 2 & 3: all gone except insomnia and some tiredness. Day 4: Tired because of insomnia; knuckle pain in left hand. This is the day of this report.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever headache muscle aches weakness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: Flu-lik symptoms - Exhaustion, body aches, Pain at inj. site 1-2 wks This lasted about 3 days and gradually got better over the week. (Same reactions w/1st Shingrix vaccine, given at same location) My first Shingrix vaccine was given in Nov'19, but I don't know the date. I had all of the symptoms of the 2nd dose. I was planning to get the 2nd dose in March 2020, but then COVID 19...
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: REDNESS, SWELLING AND RASH AROUND INJECTION SITE
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Pt received vaccines, waited in the allotted waiting area after getting vaccines. Pt brought back to exam room after experiencing vasovagal reaction. Pt was placed in dorsal recumbent position and given an ice pack that was placed under the neck.