chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Pain, Paraesthesia
Clinical narrative: Muscle cramping stinging/tingling sensation down arm
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Dizziness, Electroencephalogram normal, Magnetic resonance imaging normal, Respiratory rate increased
Clinical narrative: Approx 30m. after injection pt felt as if she might faint, was then noted by mother to be unresponsive, shaking. Started to cry, rapid respirations
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Approx 30m. after injection pt felt as if she might faint, was then noted by mother to be unresponsive, shaking. Started to cry, rapid respirations
Age: 43.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: severe swelling redness, tenderness of left upper arm with rash - 3 discrete patches
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling cold, Injection site pain, Injection site swelling, Nausea, Palpitations
Clinical narrative: Patients skin raised at injection site. She felt nauseous & had palpitations. She said she also felt cold & her arm was hurting at injection site.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effect reported; a dose of Vaqta pediatric formula was inadverently administered to a female adult patient; This spontaneous report was received from a medical assistant and refers to a 47-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JAN-2020, the patient was inadvertently vaccinated with pediatric formula of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # S002460, expiration date 15-MAY-2020 (dose was not reported), for prophylaxis. No additional adverse effect was reported. The outcome of the event was unknown.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effect reported; a dose of Vaqta pediatric formula was inadverently administered to a female adult patient; This spontaneous report was received from a medical assistant and refers to a 47-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JAN-2020, the patient was inadvertently vaccinated with pediatric formula of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # S002460, expiration date 15-MAY-2020 (dose was not reported), for prophylaxis. No additional adverse effect was reported. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram abnormal, Chills, Deafness neurosensory, Deafness unilateral, Discomfort
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Ear discomfort, Ear pain, Facial pain, Hypoacusis
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Musculoskeletal discomfort, Neck pain, Nerve injury, Ocular discomfort
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram abnormal, Deafness unilateral, Ear discomfort, Facial pain, Feeling abnormal
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Neck pain, Nerve injury, Sinus disorder, Tinnitus
Clinical narrative: hearing loss on left side; clogged ear / unusual, uncomfortable feeling in and around ear; possibly a sinus issue; noises were distorted in my left ear; Hearing loss pattern similar to nerve damage; Felt crappy; facial pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, ear feels clogged, sinus disorder, ear noises, nerve damage, feeling bad, facial pain and neck pain to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient self. The age at vaccination was not reported. Shortly after receiving vaccine, the patient experienced what he/she thought was a clogged ear, possibly a sinus issue. The patient felt crappy but muddled through the holidays. The patient went to doctor, received steroids and antibiotics due to facial pain and noises were distorted in left ear. The patient did not experience nasal discharge, fever, etc. Nothing improved after treatment, patient had an unusual, uncomfortable feeling in and around ear, neck pain, etc. The doctor suggested patient to see an ENT (ears, nose, and throat). The patient had an audiogram, which showed hearing loss on left side. Hearing loss pattern was similar to nerve damage. The events were getting worse.      Lab Comments: On an unknown date, the lab test was performed
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Breast inflammation, Psoriasis, Soft tissue inflammation
Clinical narrative: Extreme breast tissue inflammation 11/7/2019 and 2/25/2020 along with psoriasis on breast skin and nipple
Age: 52.0
Sex: F
Vaccine: TDAP, UNK, UNK
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Shivering, muscle soreness (whole body), 100 degree temp, lasted about 3 hrs - was fine in the morning
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Head banging, Injection site swelling, Pyrexia, Rash, Speech disorder developmental
Clinical narrative: Low grade fever for nine days, swelling at injection site, in day nine patient displayed a rash beginning on trunk and spreading along limbs. Displayed immediate speech regression (reduction in vocabulary volume for approximately 4 months post vaccination). Head banging on floor began on 10/9/2019 for roughly 4 month timeframe.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: She received the vaccine on 2/19/20, and then 2/20/20 had body aches, fever, nausea. She then developed a "lacy" rash  day on neck 2/21/20 that resolved by saturday 2/22. However, night of 2/22/20 and on 2/23/20 morning noticed an area of redness and warmth on her  L bicep that is not at the injection site. It  spread up the arm towards area of injection; used Hydrocrtisone cream to central part of rash and it helped reduce redness; used benadryl; used zyrtec which helped;
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: She received the vaccine on 2/19/20, and then 2/20/20 had body aches, fever, nausea. She then developed a "lacy" rash  day on neck 2/21/20 that resolved by saturday 2/22. However, night of 2/22/20 and on 2/23/20 morning noticed an area of redness and warmth on her  L bicep that is not at the injection site. It  spread up the arm towards area of injection; used Hydrocrtisone cream to central part of rash and it helped reduce redness; used benadryl; used zyrtec which helped;
Age: 4.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information was provided; the nurse reported she gave an unspecified patient an expired dose of PROQUAD; This spontaneous report was received from a nurse via a company representative, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 29-JAN-2020, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (expired product administered) ,one dosage form as prophylaxis (lot number R011216 has been verified to be a valid lot number, expiration date reported and validated as 15-OCT-2019) (concentration, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (lot number and expiry date were not reported).   No additional adverse event was reported.  Follow-up information has been received from a nurse on 17-FEB-2020.  The nurse reported that the patient was a 4-year-old female patient.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: pneumovax 23 was loaded into the pyxis on 14Feb2020 at 1057 and was administered to this patient on 16Feb2020 at 0940. The vaccine was at room temperature (69F).; No additional adverse effects reported; This spontaneous report was received from a pharmacy technician, and refers to a 62 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On 14-FEB-2020, the dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S028602 with an expiration date in 28-JUN-2021), was loaded into the system at 10: 57 and was left at room temperature of 69 degrees Fahrenheit until 16-FEB-2020 at 09:40 (72 hours), when the patient was vaccinated via intramuscular (strength, dose and frequency were not provided), for prophylaxis. As a result, it was also reported that the patient was hospitalized on an unspecified date in February 2020 (reported as "the patient was still in the hospital as it was being monitored by medical professionals"). It was also reported that there was no previous temperature excursion and that the digital data logger was not involved. No additional adverse effects were reported.  This is one of two reports received from the same reporter regarding different patients.; Sender's Comments:  US-009507513-2002USA008585:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient was vaccinated with an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a licensed practical nurse referring to a 12 months patient of unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 18-NOV-2019, the patient was vaccinated for prophylaxis with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration and dosage regimen were not reported; lot number R022223, expiration date: 12-JUL-2021).  The improperly stored of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced a temperature of below 2 Celsius degrees; 0.3 Celsius degrees multiple for 45 minutes; without a previous temperature excursion and was call because a digital data logger. No adverse effects were reported. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; A patient was administered an expired but properly stored PROQUAD vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reaction or allergies, and concomitant medications were not reported.   On 20-FEB-2020, the patient was vaccinated with an expired but properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot number R024020 had been verified to be a valid number; expiration date 19-FEB-2020) (strength, dose, frequency, route of administration, and anatomical location were not reported), the vaccine was reconstituted with a not expired sterile diluent (DILUENT MRK). No additional adverse events.
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Crying, Inappropriate schedule of product administration, Irritability, Pyrexia, Rash morbilliform
Clinical narrative: her son (patient) received one dose of both the M-M-R Il and VARIVAX vaccinations concomitantly on the same day; crying uncontrollably; super high fever; measles like rash broke out head to toe; fussy; This spontaneous report as received from a patient's mother refers to her son of unknown age.  The patient's medical history, current condition, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in 2017, it was reported that patient received one dose of both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccinations concomitantly on the same day (inappropriate schedule of product administration) during a doctor's visit for (routine immunization). Other suspect therapies included sterile diluent. On an unknown date in January 2017, (reported as 5 days later),  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccines were administered to him, the patient experienced a super high fever (pyrexia) which was around 105 degrees and a measles like rash broke out head to toe (rash morbilliform). He was also acting fussy (irritability) and was crying uncontrollably due to his adverse experience. On an unknown date in 2017 (reported as couple of days later), he was recovered from his high fever and his rash morbilliform was subsided (in about 4 or 5 days later). The outcome of rash morbilliform was reported as recovering/resolving. The outcome of irritability, inappropriate schedule of product administration and crying was unknown. Causality for the events pyrexia, rash morbilliform, irritability and crying was not reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: complaints of fever and arm pain/ the patient complained of "increased swelling and redness over the entire arm/ was diagnosed with cellulitis; Upon withdrawing the syringe from the patients arm the "luer lock" component on the syringe "fell off". The needle remained on the syringe after the syringe was removed from the arm; This spontaneous report was received from a pharmacist referring to a 53-year-old male patient. The patient did not have any pertinent medical history, drug reactions, and allergies. His concomitant medications included a flu shot in the arm.   On 15-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route in the left arm (lot # S029542 with an expiration date on 10-JUN-2021) for prophylaxis (strength was not reported).        On 15-FEB-2020, upon withdrawing the syringe from the patient's arm the "luer lock" component on the syringe "fell off'. The needle remained on the syringe after the syringe was removed from the arm.  On 17-FEB-2020, the patient called the pharmacy with complaints of fever and arm pain. The pharmacist instructed the patient to take ibuprofen (ADVIL) as treatment. Later on, the pharmacist additionally reported that the patient complained of increased swelling and redness over the entire arm.   The patient was told to go to urgent care. Subsequently, on 18-FEB-2020, the patient went to an unspecified urgent care and was diagnosed with cellulitis and given a prescription for oral cephalexin antibiotic to be taken for 10 days. It was unknown by the reporter if laboratory diagnostics and studies were performed.  The outcome of the cellulitis was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.     Upon internal review, cellulitis was considered a medically significant event.
Sex: M
Vaccine: PPV, PPV
Symptoms: Syringe issue
Clinical narrative: complaints of fever and arm pain/ the patient complained of "increased swelling and redness over the entire arm/ was diagnosed with cellulitis; Upon withdrawing the syringe from the patients arm the "luer lock" component on the syringe "fell off". The needle remained on the syringe after the syringe was removed from the arm; This spontaneous report was received from a pharmacist referring to a 53-year-old male patient. The patient did not have any pertinent medical history, drug reactions, and allergies. His concomitant medications included a flu shot in the arm.   On 15-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route in the left arm (lot # S029542 with an expiration date on 10-JUN-2021) for prophylaxis (strength was not reported).        On 15-FEB-2020, upon withdrawing the syringe from the patient's arm the "luer lock" component on the syringe "fell off'. The needle remained on the syringe after the syringe was removed from the arm.  On 17-FEB-2020, the patient called the pharmacy with complaints of fever and arm pain. The pharmacist instructed the patient to take ibuprofen (ADVIL) as treatment. Later on, the pharmacist additionally reported that the patient complained of increased swelling and redness over the entire arm.   The patient was told to go to urgent care. Subsequently, on 18-FEB-2020, the patient went to an unspecified urgent care and was diagnosed with cellulitis and given a prescription for oral cephalexin antibiotic to be taken for 10 days. It was unknown by the reporter if laboratory diagnostics and studies were performed.  The outcome of the cellulitis was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.     Upon internal review, cellulitis was considered a medically significant event.
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: complaints of fever and arm pain/ the patient complained of "increased swelling and redness over the entire arm/ was diagnosed with cellulitis; Upon withdrawing the syringe from the patients arm the "luer lock" component on the syringe "fell off". The needle remained on the syringe after the syringe was removed from the arm; This spontaneous report was received from a pharmacist referring to a 53-year-old male patient. The patient did not have any pertinent medical history, drug reactions, and allergies. His concomitant medications included a flu shot in the arm.   On 15-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route in the left arm (lot # S029542 with an expiration date on 10-JUN-2021) for prophylaxis (strength was not reported).        On 15-FEB-2020, upon withdrawing the syringe from the patient's arm the "luer lock" component on the syringe "fell off'. The needle remained on the syringe after the syringe was removed from the arm.  On 17-FEB-2020, the patient called the pharmacy with complaints of fever and arm pain. The pharmacist instructed the patient to take ibuprofen (ADVIL) as treatment. Later on, the pharmacist additionally reported that the patient complained of increased swelling and redness over the entire arm.   The patient was told to go to urgent care. Subsequently, on 18-FEB-2020, the patient went to an unspecified urgent care and was diagnosed with cellulitis and given a prescription for oral cephalexin antibiotic to be taken for 10 days. It was unknown by the reporter if laboratory diagnostics and studies were performed.  The outcome of the cellulitis was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.     Upon internal review, cellulitis was considered a medically significant event.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; patient received unspecified doses of PEDVAXHIB and ROTATEQ on 20-FEB-2020 that had been improperly stored; This spontaneous report was received from a registered nurse and refers to a 4 month old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 20-FEB-2020, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S000352, expiration date on 17-OCT-2021 (dose, route and anatomical location were not provided); and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # R033256, expiration date on 23-JUN-2020, both for prophylaxis. The vaccines were exposed to a temperature of 49.5 degree fahrenheit during 30 minutes. There was a previous temperature excursion of 49.1 degree fahrenheit during 1 hour and 48.6 degree fahrenheit during 1.5 hours. It was reported that digital data logger was involved. No symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Improperly stored ROTATEQ administered to patient on 14-FEB-2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 14-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S005878, expiration date on 25-DEC-2020 (dose was not provided) for prophylaxis. The vaccine was exposed to a temperature above 47 degree fahrenheit/ 9 degree celsius (46.84F) during 15 minutes. It was reported that digital data logger was involved. There was not previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was administered improperly stored VARIVAX; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 24-FEB-2020, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) (lot # S025610, expiration date 18-AUG-2021) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (STERILE DILUENT).   The improperly varicella virus vaccine live (oka/merck) (VARIVAX) was stored at temperature 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.6 Fahrenheit) for 44 hours and 42 minutes. There was previous temperature excursion: 15 degrees Fahrenheit to 46 degrees Fahrenheit (30.4 Fahrenheit) for 6 hours and 12 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (30.4 Fahrenheit) for 6 hours and 12 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (16 Fahrenheit) for 2 hours and 18 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.1 degrees Fahrenheit) for 1 hour; 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.7 Fahrenheit) for 30 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.4 Fahrenheit) for 2 hours and 6 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (9.9 Fahrenheit) for 1 hour. The data logger was not involved. No additional adverse event was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA009560:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had upset stomach. The reporter asked how long would the side effects last.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Headache; tiredness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, tiredness and upset stomach. On an unknown date, the outcome of the headache, tiredness and upset stomach were unknown.   It was unknown if the reporter considered the headache, tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache, tiredness, and upset stomach. The reporter asked how long would the side effects of headache, tiredness, and upset stomach last.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Got sick with first one; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and got sick. The reporter inquired that what if he or she not take second dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Eye pruritus, Headache
Clinical narrative: rash that moved from chest to her face; rash that moved from chest to her face with itching; Skin pain; itchy eyes; muscle ache; Weakness; Fever; Chills; Headache; abdominal pain; Heart palpitations; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, 1 day after receiving Shingrix, the patient experienced rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation. On an unknown date, the outcome of the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix patient experienced a rash that moved from chest to her face associated with itching and skin pain. The patient also experienced itchy eyes, muscle ache, weakness, fever, chills, headache, abdominal pain, and heart palpitations. The patient started experiencing the side effects the day after vaccination. The patient reported the events to the doctor's office on 29th January 2019. The patient had recovered completely. The reporter did not consent to follow up. This case has been linked with case US2020028071, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain of skin, Palpitations, Pruritus, Pyrexia
Clinical narrative: rash that moved from chest to her face; rash that moved from chest to her face with itching; Skin pain; itchy eyes; muscle ache; Weakness; Fever; Chills; Headache; abdominal pain; Heart palpitations; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, 1 day after receiving Shingrix, the patient experienced rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation. On an unknown date, the outcome of the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix patient experienced a rash that moved from chest to her face associated with itching and skin pain. The patient also experienced itchy eyes, muscle ache, weakness, fever, chills, headache, abdominal pain, and heart palpitations. The patient started experiencing the side effects the day after vaccination. The patient reported the events to the doctor's office on 29th January 2019. The patient had recovered completely. The reporter did not consent to follow up. This case has been linked with case US2020028071, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash that moved from chest to her face; rash that moved from chest to her face with itching; Skin pain; itchy eyes; muscle ache; Weakness; Fever; Chills; Headache; abdominal pain; Heart palpitations; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, 1 day after receiving Shingrix, the patient experienced rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation. On an unknown date, the outcome of the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, skin pain, eye pruritus, muscle pain, weakness, fever, chills, headache, abdominal pain and palpitation to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix patient experienced a rash that moved from chest to her face associated with itching and skin pain. The patient also experienced itchy eyes, muscle ache, weakness, fever, chills, headache, abdominal pain, and heart palpitations. The patient started experiencing the side effects the day after vaccination. The patient reported the events to the doctor's office on 29th January 2019. The patient had recovered completely. The reporter did not consent to follow up. This case has been linked with case US2020028071, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back injury, Head injury, Headache, Injection site pain, Loss of consciousness
Clinical narrative: injection site pain; hit her head; hurt her back; woke up with a dull headache; nausea; passed out; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2013).   On 19th February 2020 13:47, the patient received Shingrix. In February 2020, 12 hrs 13 min after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), head injury, back injury, headache and nausea. On 19th February 2020, the patient experienced injection site pain. On an unknown date, the outcome of the passed out, head injury, back injury and nausea were unknown and the outcome of the injection site pain and headache were recovering/resolving.   It was unknown if the reporter considered the passed out, injection site pain, head injury, back injury, headache and nausea to be related to Shingrix.  Additional information was provided as follows: The patient was weighs 100 lbs less than her husband. The patient received vaccine at 1:47 PM, she woke up at 2:00 AM, walked to the bathroom , passed out , hit her head and hurt her back. The patient was taken to the hospital, her vital signs were checked and she was released. The patient woke up with a dull headache in the morning on the day of reporting. The patient did not feel that she should get the same dose as someone much larger. The reporter consented to follow up. Emergency visit required. The outcome of the event injection site pain and headache were reported in source document as fatal, however it was reported as recovering and resolving in system.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: injection site pain; hit her head; hurt her back; woke up with a dull headache; nausea; passed out; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2013).   On 19th February 2020 13:47, the patient received Shingrix. In February 2020, 12 hrs 13 min after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), head injury, back injury, headache and nausea. On 19th February 2020, the patient experienced injection site pain. On an unknown date, the outcome of the passed out, head injury, back injury and nausea were unknown and the outcome of the injection site pain and headache were recovering/resolving.   It was unknown if the reporter considered the passed out, injection site pain, head injury, back injury, headache and nausea to be related to Shingrix.  Additional information was provided as follows: The patient was weighs 100 lbs less than her husband. The patient received vaccine at 1:47 PM, she woke up at 2:00 AM, walked to the bathroom , passed out , hit her head and hurt her back. The patient was taken to the hospital, her vital signs were checked and she was released. The patient woke up with a dull headache in the morning on the day of reporting. The patient did not feel that she should get the same dose as someone much larger. The reporter consented to follow up. Emergency visit required. The outcome of the event injection site pain and headache were reported in source document as fatal, however it was reported as recovering and resolving in system.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Strong chills, aching muscles particularly legs, headache, fatigue, nausea
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: Muscle pain at injection site, chills, feverish, malaise, mild headache, woozy/slight dizziness, weakness.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Muscle pain at injection site, chills, feverish, malaise, mild headache, woozy/slight dizziness, weakness.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Arthritis, Chills, Hyperaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: experienced intense pain in shoulder,  pain became sharp upon using arm to reach up - started at approximately midnight shoulder and arm were extremely sensitive to touch (even fabric) woke up around 3am with shivering/chills at that time his arm was extremely painful lasted about 5 1/2 hours at 5am shoulder and arm were sore but movable without intense pain does have a history of arthritis in shoulder