chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th December 2018, less than an hour after receiving SHINGRIX, the patient experienced headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right deltoid. The pharmacist stated that the patient developed a severe headache (so bad that they could not function), nausea, vomiting, body aches, swelling and redness at injection site (about a 2 inch diameter) within an hour after receiving the SHINGRIX. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th December 2018, less than an hour after receiving SHINGRIX, the patient experienced headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the headache, nausea, vomiting, general body pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right deltoid. The pharmacist stated that the patient developed a severe headache (so bad that they could not function), nausea, vomiting, body aches, swelling and redness at injection site (about a 2 inch diameter) within an hour after receiving the SHINGRIX. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The pharmacist stated that patient was not feel good for a long time after receiving SHINGRIX. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that some patients experienced a sore arm from the 1st dose of SHINGRIX and might not want to receive the 2nd dose of SHINGRIX. No specific patient information was provided by the HCP.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (subcutaneous). On 10th December 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In December 2018, the patient experienced injection site swelling, injection site erythema and discomfort. On an unknown date, the outcome of the injection site swelling, injection site erythema and discomfort were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX subcutaneously, which led to wrong route of vaccine administration. Less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site. The patient felt very uncomfortable. The pharmacist did not know when the events started and consented to follow up. This case has been linked with case US2018226104, reported by the same reporter.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU4, IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional (office staff). This case involves an adult patient of unknown demographics who was vaccinated with a doses of IPOL, FLUZONE QUADRIVALENT, DAPTACEL and PENTACEL and while treated with TUBERSOL (lot number and expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and poor quality product administered. On 20 Oct 2018, alarm recorded excursion for 8 hours and 5 minutes, reached (-1.5) C. Oct 21st, excursion for 19 hours below 0 C was recorded and on Oct 22nd excursion for 6 hours below 0 C. It was not reported whether the patient experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional and an additional information was received on 05-Dec-2018 by the same reporter. This case involves a 48 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT, lot UJ046AB in the shoulder nos. on an unknown date at 07:42 AM (reported as yesterday) that was exposed to 11 F. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to product storage error and poor quality product administered. It was not reported whether the patient experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Back pain, Pain in extremity, Pyrexia
Clinical narrative: Had flu shot Thursday before Thanksgiving. Next day mild fever. Following day had severe joint pain, limbs, back, which has persisted. Called HD today. Patient called health department. Front desk called me. This is all I know not his provider though I advised him to call his doctor today.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Limb discomfort, Nausea, Pain
Clinical narrative: Patient is a 69 yo female that C/O right arm pain with some intermittent nausea that started approx. 5hrs ago. She noted pain originates from site where Pneumococcal vaccine was given this morning. Mild redness around area without appreciable swelling. No chest pain, no cough/congestion. Denies recent illness. No numbness/tingling into RUE. Afebrile. She had taken 2 doses of Ibuprofen without significant improvement. Sharp/shooting pain that she rates 10/10.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Lethargy, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Patient was seen on 10/12/2018 for her month well child check. She was growing well and had a normal physical exam. Vaccines given a 0930. Developed 1 episode of vomiting later that evening but continued to nurse well. Felt febrile to mother about 16 hours after receiving vaccines, temperature was taken and was 104.7 and rising per mom. She was immediately brought to Hospital ED, ED reports initial temp of 38.6 C. She was alert with a social smile. Pulse ox 99% RA, Resp 26, pulse 147. Exam revealed no source of fever. Labs were done. Patient was D/C with a Dx of febrile syndrome. On 10/14/2018 mom felt she was lethargic. Temp taken was 96-97 F. She was bundled and warmed and T returned to normal that day. Patient was seen in our office on 10/15/18. Her exam then was normal and she appeared well. She was seen on 12/20/18 for her 6 month PE growth and development were age appropriated and normal.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Client was given a flu vaccine at 10:00 AM. Client started having a seizure at 10:01. Called EMS at 10:02. Client was stable when left with EMS.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: 11/27 - talked to mother getting better w/ice and ibuprofen 400 mg.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Dyspnoea
Clinical narrative: Difficulty breathing, heavy chest, pain in lower back. Dissipated after 10-15 minutes. All seems fine now.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain
Clinical narrative: Pain had injection site reaction. Thought redness looked like streaks and had his orthopedic doctor look at it while have a pre-surgery appointment. MD sent in rx for KEFLEX 500mg.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Shivering, fever. Headache, soreness, fatigue.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, significant body aches, tired. This started about 12 hours after the shot and continued for approximately 24 hours. I had the same reaction the first time I got the shot but since I was prepared for it and quickly took Ibuprofen, it was not as bad. However, I had to take Ibuprofen regularly during the period to feel even halfway decent.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Induration, Skin warm, Swelling
Clinical narrative: 10 cm x 8 cm, raised, hard, red, hot to the touch. Seen and treated for cellulitis on 12/19/18 at the clinic.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Vaccine given to patient aged 4 months old, but only supposed to be given to patients aged 4yrs plus. Once discovered, patient was monitored for a few hours and then asked to report to ED if any adverse reactions occurred. Mother of infant did report that ED visit was needed that evening when patient had a high fever of 104. Patient sent to Medical Center. Patients fever reportedly subsided and is now fine with no further symptoms of adverse reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Flat red rash on arms, legs and cheeks, very itchy, 7 hours after administration.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Electrocardiogram, Eye movement disorder, Fall, Malaise
Clinical narrative: Patient received her Influenza vaccine FLUZONE 0.5ml #UJ087AB exp 06/30/2019 around 10:15am at Public Health's Fire Department Immunization Clinic. RN administered the vaccine. Afterwards, patient walked over to her brother to comfort him because he was feeling unwell after his vaccinations and then walked back over to her mom to comfort her mom because her mom just received her flu shot after patient. Around 5 minutes after patient's vaccination, mom quickly grabbed patient from falling over and had patient laying on her back on mom's lap. I witnessed patient's eyes were rolled up, coloring was pale, head flopped backwards. I helped mom lay patient on the ground. Mouth was clenched shut and unable to be opened by mom. Patient then came out of it, blinked her eyes, unclenched her jaw, and muttered something about her mouth hurting. Patient's medical event lasted around 10 seconds. Someone retrieved a group of paramedics that were in their kitchen area. Patient was up sitting in her mom's lap, but very quiet and burying her head into mom's chest. Paramedics arrived, visually assessed her, discussed event with Mom and myself, and offered to take vitals. Patient was very shy, so it was not pursued by paramedics or by mom. Paramedics offered to take patient by ambulance to hospital. Mom declined and stated that she would take patient to hospital close to home or Hospital. Patient and family left around 10:40am. Patient was alert but drowsy looking when she left.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Oral pain, Pallor, Posture abnormal, Somnolence
Clinical narrative: Patient received her Influenza vaccine FLUZONE 0.5ml #UJ087AB exp 06/30/2019 around 10:15am at Public Health's Fire Department Immunization Clinic. RN administered the vaccine. Afterwards, patient walked over to her brother to comfort him because he was feeling unwell after his vaccinations and then walked back over to her mom to comfort her mom because her mom just received her flu shot after patient. Around 5 minutes after patient's vaccination, mom quickly grabbed patient from falling over and had patient laying on her back on mom's lap. I witnessed patient's eyes were rolled up, coloring was pale, head flopped backwards. I helped mom lay patient on the ground. Mouth was clenched shut and unable to be opened by mom. Patient then came out of it, blinked her eyes, unclenched her jaw, and muttered something about her mouth hurting. Patient's medical event lasted around 10 seconds. Someone retrieved a group of paramedics that were in their kitchen area. Patient was up sitting in her mom's lap, but very quiet and burying her head into mom's chest. Paramedics arrived, visually assessed her, discussed event with Mom and myself, and offered to take vitals. Patient was very shy, so it was not pursued by paramedics or by mom. Paramedics offered to take patient by ambulance to hospital. Mom declined and stated that she would take patient to hospital close to home or Hospital. Patient and family left around 10:40am. Patient was alert but drowsy looking when she left.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The patient had soreness in the arm that became severe within a day or so. She had a swollen arm that was hot. She also got flu like symptoms with a fever (up to 103 per patient) and headache. This lasted until the following Monday and lasted almost a week. On the following Monday she started to feel better and was getting better by the time she came in on 12-20. The patient still reported some redness at the site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: The patient had soreness in the arm that became severe within a day or so. She had a swollen arm that was hot. She also got flu like symptoms with a fever (up to 103 per patient) and headache. This lasted until the following Monday and lasted almost a week. On the following Monday she started to feel better and was getting better by the time she came in on 12-20. The patient still reported some redness at the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Influenza like illness, Malaise
Clinical narrative: Flu like, very ill, fever, chills, sweats, headache (migraine like), weakness, could not get out of bed. Called pharmacy told me to take TYLENOL should subside in 1-2 days if not go to the doctors. Started to subside after 24 hours
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pyrexia
Clinical narrative: Flu like, very ill, fever, chills, sweats, headache (migraine like), weakness, could not get out of bed. Called pharmacy told me to take TYLENOL should subside in 1-2 days if not go to the doctors. Started to subside after 24 hours
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-APR-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-DEC-2016 and 14-MAR-2017, the patient was treated for shingles and postherpetic neuralgia, respectively. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Gastric pH decreased, Loss of consciousness, Migraine, Muscle tightness
Clinical narrative: Uncontrollable shaking in bed for two hours. Excessive stomach acid. Tense muscles in shoulder, neck and back. Bad migraine type headache. Nausea, throwing up next morning. Lightheaded, passing out, in AM.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Uncontrollable shaking in bed for two hours. Excessive stomach acid. Tense muscles in shoulder, neck and back. Bad migraine type headache. Nausea, throwing up next morning. Lightheaded, passing out, in AM.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-JUN-2010, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-DEC-2016, the patient was treated by a physician/MD for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 10-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 28-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 04-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the son who reported for her mother. The age at the vaccination was not reported. The reporter reported that her mother received SHINGRIX vaccine. The patient was complaining of just about every symptoms. No rash or shortness of breath was reported. The reporter wanted to know how long does the symptoms lasts. The reporter left chat before any other information could be obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness over most of upper (R) arm, lasting greater than 10 days. Also felt fluish for 48 hours.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Myalgia/arthralgia - (L) sided myalgia in arm. Shoulder, neck, and (L) sided knee and leg pain 9-5-18.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient describes having pain in arm and unable to raise arm on 11/05/2018.
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: PT STATED HE HAD EXTREME FATIQUE (FELT LIKE HE COULDN'T GET UP) DIZZINESS, HEADACHE, NAUSEA WITHOUT VOMITING (12/20/19). CALLED HIM BACK AFTERNOON OF 12/21 AND HE SAID THAT HE FELT ABOUT 80% BETTER.
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Discomfort, Headache, Injection site discharge, Injection site swelling
Clinical narrative: Per patient: "The injection in my right arm swelled and is black and blue. It kept me awake last night with fever and chills and a headache. My arm was so painful I could not sleep. It was very uncomfortable to shake uncontrollably."
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Insomnia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Per patient: "The injection in my right arm swelled and is black and blue. It kept me awake last night with fever and chills and a headache. My arm was so painful I could not sleep. It was very uncomfortable to shake uncontrollably."
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Mouth swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: Patient developed swelling of his lips, mouth and jaw and also had a red rash on his torso. He did not seek medical attention and did not take any BENADRYL. The swelling and rash spontaneously resolved within 24 hours.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Urticarial rash, non anaphylactic reaction at site and generalized urticarial rash.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Mild swelling and redness, warm to the touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Patient had large palm sized red mark circling injection site. It had been 2 days after injection and the area had gotten worse and warm. She also had a huge red ring around her armpit that had come right away, but had gone down some on day 2. Husband is a retired PA and was monitoring it from home.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, DTAP, FLU4, HEP, MMR, MNQ
Symptoms: Headache
Clinical narrative: Patient developed a splitting head ache - stated felt like somebody hit her in the head.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient is complaining of pain in his left arm from the elbow to mid-arm.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Localized redness, warm to the touch, induration at injection site patient placed on KEFLEX due to history of cellulitis and being immunosuppressed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Tuesday the 18th and that night was up many times to go to the bathroom and was SOOOO thirsty! The site of injection was so painful I could not lay on it, roll over or raise my arm, and it is also still red and warm - very listless, a bit chilled, and painful right wrist and knee now/then with movement.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Listless, Nocturia, Pain, Thirst
Clinical narrative: Tuesday the 18th and that night was up many times to go to the bathroom and was SOOOO thirsty! The site of injection was so painful I could not lay on it, roll over or raise my arm, and it is also still red and warm - very listless, a bit chilled, and painful right wrist and knee now/then with movement.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Throat tightness, Tremor
Clinical narrative: Fever reaching 105 degrees (24 hours post vaccination). Severe chills and shaking. Throat tightening - subsided and needed no further treatment. Severe body aches. All symptoms started approx. 4 hours post vaccination and intensified every hour until about 48 hours post vaccine and then fever decreased and body aches diminished slightly. Treated with extra strength TYLENOL. Called her MD - no treatment needed such as ER or Hospitalization.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 17-years-old patient of an unspecified gender received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date with outcome of unknown. Information on the batch number has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-MAR-2014, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JUL-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-FEB-2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-DEC-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In October 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In November 2011, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-AUG-2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient's mother). A 18-year-old male patient received TRUMENBA, via an unspecified route of administration, in Jun2018, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced pain at injection site in 2018 with outcome of unknown, fatigue in 2018 with outcome of unknown, headache in 2018 with outcome of unknown, muscle pain in 2018 with outcome of unknown. The pharmacist reported that it was unclear to her from the product information that a second dose was even necessary. Product information stated "the effectiveness of the two-dose schedule of TRUMENBA against diverse N. meningitidis serogroup B strains has not been confirmed". That was confusing, based on what she was reading, two doses may not give effectiveness. No follow-up attempts possible. No further information expected.