chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included multiple sclerosis. Concomitant products included Herpes zoster (Shingrix).   On 20th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: On 14th March 2019, the patient received first dose of Shingrix concomitantly. The patient experienced fever of 101 degree C after 2nd dose of Shingrix.  The health care professional noted that the fever of 101 has lasted for over 24 hours after dose 2. This case was linked to case US2019092274 for dose 1 of the same patient.      Lab Comments: Lab test performed in May 2019
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Nasopharyngitis, Upper respiratory tract congestion
Clinical narrative: cold; redness at injection site; stuffiness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nasopharyngitis (received 1st dose on 27th December 2018, refer link case US2019GSK092788).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cold, injection site erythema and upper respiratory tract congestion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the cold, injection site erythema and upper respiratory tract congestion were unknown.   It was unknown if the reporter considered the cold, injection site erythema and upper respiratory tract congestion to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's husband. On Monday, the patient received Shingrix and since then, the patient felt like she was getting a cold. At first it was in her chest but now feels it might be in her upper respiratory due to her stuffiness. The patient dose not feel bad though. The patient also experienced redness at the injection site. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore Arm; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine and experienced sore arm that lasted for 5 days, and feeling of malaise that lasted for 4 days. The reporter did not consent to follow-up. No further details were provided. This case was linked with case US2019090298 (husband's case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient got the dose Shingrix shot and then experienced shingles. The pharmacist asked how long they need to wait to give her the second shot. It was reported that the patient had been symptom free for 3 days. The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Fever; Malaise; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included multiple sclerosis.   On 14th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, malaise and influenza-like symptoms. On an unknown date, the outcome of the fever, malaise and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever, malaise and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows:  There was no resolution date for fever, malaise, and flu like symptoms. For tolerance for dose 2, refer case US2019GSK095707. There is a discrepancy with respect to the outcome of the events fever malaise, and flu like symptoms. In Agency core the outcome is reported as recovered for all three events, however in provided source document it is recovering/resolving with sequelae. The outcome of these events retains as per the Agency structural field.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Sunday, late afternoon.  Receive shot at 4pm. Within an hour or two there was soreness and redness.  By later, about 7 or 8 pm , I had temp of 101.6, chills, general malaise.   Monday morning, I experienced more swelling of the site, redness and  heat.   Temp was 99.6.  No appetite. Very tired Tuesday morning:  Same symptoms but increased redness and swelling. Went primary care physician.  She felt there was an infection and prescribed an antibiotic.  Spoke with pharmacist and he recommended reporting the reaction.  Wednesday morning:  Felt  much less tired. Redness gone. Swelling and site soreness are almost gone.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sunday, late afternoon.  Receive shot at 4pm. Within an hour or two there was soreness and redness.  By later, about 7 or 8 pm , I had temp of 101.6, chills, general malaise.   Monday morning, I experienced more swelling of the site, redness and  heat.   Temp was 99.6.  No appetite. Very tired Tuesday morning:  Same symptoms but increased redness and swelling. Went primary care physician.  She felt there was an infection and prescribed an antibiotic.  Spoke with pharmacist and he recommended reporting the reaction.  Wednesday morning:  Felt  much less tired. Redness gone. Swelling and site soreness are almost gone.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Sunday, late afternoon.  Receive shot at 4pm. Within an hour or two there was soreness and redness.  By later, about 7 or 8 pm , I had temp of 101.6, chills, general malaise.   Monday morning, I experienced more swelling of the site, redness and  heat.   Temp was 99.6.  No appetite. Very tired Tuesday morning:  Same symptoms but increased redness and swelling. Went primary care physician.  She felt there was an infection and prescribed an antibiotic.  Spoke with pharmacist and he recommended reporting the reaction.  Wednesday morning:  Felt  much less tired. Redness gone. Swelling and site soreness are almost gone.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: skin lesions across her abdomen, indicate "Shingles"; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 26-JUL-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles(herpes zoster). Several months after the zoster vaccine live (ZOSTAVAX) vaccine was administered, the pt developed skin lesions across her abdomen. Her records indicated "Shingles", for which she was prescribed valacyclovir. The doctor also documented the rash with photos. As a result, the pt sustained personal injuries. Further, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expense and other economic and non-economic damages.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 68 years old female patient(pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. The pt was prescribed the zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In May 2015 , the pt was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the pt was treated by a physician at medical office for the following injuries resulting from the pt's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. Causality assessments were related.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Feeling cold, Headache
Clinical narrative: I took the shot April 8, 2019 in my right arm I got shivering so bad I couldn't get warm. I had a fever and weak I almost fell down. My granddaughter got hold of my arm and helped me to my back. I threw up several times. Had belly pain it made me get a real bad headache. I didn't know what was going on. Went back to pharmacy they said that they couldn't give me nothing had to wear off. My heart was racing real fast. I feel like people should know I will never take the shot again. I thought that my heart was going to come out of my throat how fast my heart was beating. It took me rest of the week to get over that event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Vomiting
Clinical narrative: I took the shot April 8, 2019 in my right arm I got shivering so bad I couldn't get warm. I had a fever and weak I almost fell down. My granddaughter got hold of my arm and helped me to my back. I threw up several times. Had belly pain it made me get a real bad headache. I didn't know what was going on. Went back to pharmacy they said that they couldn't give me nothing had to wear off. My heart was racing real fast. I feel like people should know I will never take the shot again. I thought that my heart was going to come out of my throat how fast my heart was beating. It took me rest of the week to get over that event.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Chills, very swollen arm, skin on arm hot and bright red. All this cleared up only to leave me with arm pain that has continued to today
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: mild pain and tenderness at injection site after 3 months
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-FEB-2017, the pt was inoculated with ZOSTAVAX vaccine (lot number, dosage, vaccination site and route of administration not provided), as recommended for routine adult health maintenance for its intended purpose: the prevention of shingles. On an unknown date, shortly after receiving ZOSTAVAX, the pt suffered Herpes Zoster and acute ischemic left middle cerebral artery stroke. As a direct and proximate result of ZOSTAVAX, the pt's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Further, as a direct and proximate result of the Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event of Acute Ischemic Left Middle Cerebral Artery Stroke was determined to be medically significant. The events of acute ischemic left middle cerebral artery stroke and herpes zoster were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: fever / high fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a infant female patient who received HAV (Havrix) (batch number 9TL92, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, less than a year after receiving Havrix, the patient experienced fever (serious criteria hospitalization). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination, the patient had high fever. The patient's parent took the patient to hospital via ambulance and was admitted to the hospital.  The patient had additional vaccines at visit. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, Pain, Product preparation issue
Clinical narrative: Soreness; Product administration  issue; Inappropriate dose of vaccine administered; This case was reported by a non-health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date unknown) for prophylaxis.   On 28th March 2019, the patient received the 2nd dose of Shingrix. On 28th March 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This case was reported by the office manager. The patient was erroneously given adjuvant only (no antigen), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Office was not aware of guidance to wait 4 weeks before giving correct dose and gave a correct dose same day (28th March 2019).  No adverse events were reported, thus far from patient, to reporter knowledge. The reporter agreed to be followed up.   Follow up information received from the non-health professional on 24th April 2019: The patient demographic details were updated. On 29th March 2019, 1 day after receiving Shingrix, the patient experienced soreness. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingrix. This case was a medication error with harm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain
Clinical narrative: pain; Wrong route of administration; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 17th May 2019, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain. The reporter stated that, the patient was inadvertently given Shingrix subcutaneously which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had received first dose of Shingrix elsewhere and developed red circumferential rash on arm, large area. The reporter did not have lot or expiration date, as it was given elsewhere.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This case was reported by a pharmacist via call center representative and described the occurrence of axillary lymph nodes enlarged in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 25th May 2021) for prophylaxis.   On 23rd February 2019, the patient received the 1st dose of Shingrix .5 ml. On 24th February 2019, 1 days after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was not recovered/not resolved.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were reported as follows: The patient received his 1st dose of Shingrix, the next day he experienced a swollen lymph node under the arm where he received the shot.  It was unknown how long it took to resolve. The reporter had consented to follow up.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on both inner thigh; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In February 2019, 14 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Two weeks after receiving the vaccine, the patient developed a rash on both inner thighs. Emergency Room (ER) visit was required. Reporter consented to follow-up. There is a discrepancy with respect to the outcome of the events rash. In Argus core the outcome is reported as not recovered, however in provided source document it is recovering/resolving. The outcome of this events retains as per the structural field.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: RASH ON BODY FOR THREE DAYS
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: No adverse event or outcome, no associated symptoms
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was administered a dose of improperly stored ROTATEQ; This spontaneous has been received from a medical assistant, concerning an approximately 7 week patient of unknown gender and ethnicity.    The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 07-MAR-2019, the patient received a first dose of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002700 and expiration date 24-AUG-2019), taken orally as prophylaxis. On 15-MAY-2019, the patient received the second dose of vaccine.   In addition, the vaccine was exposed to temperature: 1.2C for timeframe 30 minutes with previous excursion: -2.13C for 3 hours. The excursion call was made by a data logger. No adverse effects reported.  This is the second of the three patients.; Sender's Comments:  US-009507513-1905USA011943: US-009507513-1905USA012681:
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms; This case was reported by a pharmacist via call center representative and described the occurrence of muscle spasm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was unknown.   It was unknown if the reporter considered the muscle spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced muscle spasm. The healthcare professional was not at work and could not provide patient demographics, lot number, or expiration dates. The healthcare professional did not provide any additional information. The reporter stated that the patient is a physician and would be contacting GSK with additional details. This case has been linked with case US2019GSK095730 (1st dose case), reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Body aches, pain at injection site restricted range of motion. low grade fever x 3 days
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Irritability
Clinical narrative: Patient with prolonged crying irritability x 24 hours
Age: 1.25
Sex: F
Vaccine: DTAP, DTAP, DTAP
Symptoms: Expired product administered
Clinical narrative: Doctor administered an expired dose. Dose expired on 5/17.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Vaccination error
Clinical narrative: no adverse events the vaccine was given in error.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Started 5/25/19 , unilateral rash/blisters (left side-axillary,cheek, ear, thigh). Encouraged to rotate OTC Ibuprofen/Tylenol
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Herpes zoster, Immunosuppression, Pneumonia, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly thereafter, the patient developed a severe case of shingles, the first of several outbreaks. The first outbreak lasted three weeks, and after that event her immune system was suppressed, and she got pneumonia which hospitalized her. The patient required rehab to walk again. After her second outbreak, she was diagnosed with post herpetic neuralgia. As a result of vaccination the patient sustained personal injuries. Further, as a tragic consequence of vaccination the patient suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events of pneumonia and post herpetic neuralgia was not reported. The outcome of shingles was not recovered. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the events of shingles, immune system was suppressed and pneumonia were determined to be disabling. Upon internal review, the event of pneumonia was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the pt was administered with the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a clinic, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, pt suffered from injury shingles, resulting from the zoster vaccine live (ZOSTAVAX). Pt was treated by a doctor at clinic. The outcome of the event was unknown. The event was considered to be related to the zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 76-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, at the age of approximately 70-year-old, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (lot#, expiration date, dose, dose# and route not specified). On an unknown date, the patient was treated in a dermatology center for the following injuries resulting from the patient's ZOSTAVAX use: herpes zoster with ophthalmic complications. At the time of the report, the outcome of ophthalmic herpes zoster and herpes zoster was unknown. The reporter considered that herpes zoster and ophthalmic herpes zoster were related to ZOSTAVAX. Upon internal review, ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: MMR, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: limit the number of vaccines he received (MMRII and ROTATEQ); Information has been received from the patient's mother who was also a speech pathologist, referring to a male patient of unknown age. The patient's concomitant medications and drug reactions/allergies were not reported. The patient had down syndrome and due to that was immune compromised and the patient had stomach issues.   The reporter wanted to limit the number of vaccines the patient received. The patient had to get measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, route of administration, lot number and expiration date were unknown) for prophylaxis at his six-month visit and she was considering holding the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (frequency, route of administration, lot number and expiration date were unknown) for prophylaxis to limit the number of vaccines he received (inappropriate schedule of product administration). No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced an episode of shingles that resolved less than 4 weeks before the reporting date. No additional details provided.  The lot number and expiration date not provided.
Sex: M
Vaccine: MENB, TDAP
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: Severe headache; flu-like symptoms; feeling terrible; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 20-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) at single dose, and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), at unspecified dose; both via unspecified routes of administration on unspecified dates for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache and flu-like symptoms and was feeling terrible for 30 hours after receiving meningococcal group b rlp2086. It was reported that meningococcal group b rlp2086  was given with Tdapmin separate arms. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: MDV Polio (Ipol) was exposed to a temperature excursion and may have been given to a patient, no adverse event; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA137200, 2019SA139565 and 2019SA139569 (same reporter).  This case involves a male patient of an unknown age who received vaccine IPV (VERO) [IPOL] lot P1A171M, expiry date: 24-Apr-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine MDV Polio (Ipol) that was exposed to a previously reported temperature excursion and may have been given to 3 patients.  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: MDV Polio (Ipol) that was exposed to a previously reported temperature excursion; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient an unknown age who was vaccinated with IPV (VERO) [IPOL] (Lot P1A171M, Exp date: 24-Apr-2020) vaccine which was exposed to higher temperature.   This case is linked with cases id -2019SA139565, 2019SA139568, 2019SA137200.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to Incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine stored at temperature outside the recommended range (Ipol) that was exposed to a previously reported temperature excursion and was given to patient).   It was not reported if the patient experienced any adverse event following vaccination.  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: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Daptacel administered to a patient 3 days past the expiration date; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case involves patient with unknown age and gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that Daptacel administered to a patient 3 days past the expiration date.  It was unknown whether patient experienced any adverse reaction after the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. Information on the batch number was requested.
Age: 17.0
Sex: F
Vaccine: TDAP, TYP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel,Typhim Vi,Tubersol(open) that were administered after the excursion, No AE; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number, expiry date, dose, route and site of administration were not reported for both) and TUBERCULIN TEST [TUBERSOL](lot - C5568AA, 05-Apr-2021 via intradermal route in left forearm) after the excursion, on 20-May-2019.  The other products that were exposed were Acthib, Ipol, Imogam, Imovax and Tenivac. All open products were discarded.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  It was reported as the excursion happened from 18May 2019 to 20 May 2019.1 degrees C was the lowest temp reached. The total amount of time out of range was 24 hours. Tubersol dose that was stored outside of range. The Tubersol vial used was at 1 C for 24 hrs.  No adverse event specifically reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for TYPHIM VI and ADACEL.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever, given infants acetaminophen
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reports severe muscle stiffness and pain that began in the neck and later radiated down through her back and leg  and lasted about one week
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Allergy test positive, Autism spectrum disorder, Developmental delay, Food allergy, Milk allergy
Clinical narrative: Healthy, normal developing normal, no problems , illnesses or allergies until last series of immunizations. After last immunizations Vomiting , fever, severe rash all over the body that lasted about 4 months. Developed skin problems, developed eggs allergies, milk sensitivity. It caused developmental delays. Diagnosed with autism on May, 2017.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Skin disorder, Skin test, Speech disorder developmental
Clinical narrative: Healthy, normal developing normal, no problems , illnesses or allergies until last series of immunizations. After last immunizations Vomiting , fever, severe rash all over the body that lasted about 4 months. Developed skin problems, developed eggs allergies, milk sensitivity. It caused developmental delays. Diagnosed with autism on May, 2017.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Healthy, normal developing normal, no problems , illnesses or allergies until last series of immunizations. After last immunizations Vomiting , fever, severe rash all over the body that lasted about 4 months. Developed skin problems, developed eggs allergies, milk sensitivity. It caused developmental delays. Diagnosed with autism on May, 2017.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In November 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes Zoster; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster and post herpetic neuralgia. On an unspecified date, the patient was treated by a physician and nurse for herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was administered a dose of improperly stored ROTATEQ; This spontaneous has been received from a medical assistant, concerning an approximately 8 week patient of unknown gender and ethnicity.    The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-MAR-2019, the patient received a dose of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002700 and expiration date 24-AUG-2019), taken orally as prophylaxis.  In addition, the vaccine was exposed to temperature: 1.2C for timeframe 30 minutes with previous excursion: -2.13C for 3 hours. The excursion call was made by a data logger. No adverse effects reported.  This is the third of the three patients.; Sender's Comments:  US-009507513-1905USA012679: US-009507513-1905USA011943:
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash develop in the patient, from the injection site down to the elbow; Rash develop in the patient, from the injection site down to the elbow; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that rash develop in the patient, from the injection site down to the elbow on an unspecified date. The outcome of the events was unknown.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: MDV Polio (Ipol) was exposed to a temperature excursion and may have been given to a patient, no adverse event; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA137200, 2019SA139568 and 2019SA139569 (same reporter).  This case involves male patient of an unknown age who received vaccine IPV (VERO) [IPOL] lot P1A171M, expiry date: 24-Apr-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine stored at temperature outside the recommended range ((Ipol) that was exposed to a previously reported temperature excursion and was given to patient).  It was unknown if any adverse event was occurred.   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: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: facility gave an expired vaccine shot (expired by 4 days) of Daptacel to a patient; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used. It was reported that the facility gave an expired vaccine shot (expired by 4 days) of Daptacel and reporter did not know any information about the patient.  It was unknown if any adverse event was occurred.   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.  Information on the batch number was requested.  Documents held by sender: none.