chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Vomiting
Clinical narrative: The first day the patient received the GARDASIL 9 shot, the patient experienced soreness in arm; The first day the patient received the GARDASIL 9 shot, the patient experienced inflammation at the location of the shot; The first day the patient received the GARDASIL 9 shot, the patient experienced headaches; The first day the patient received the GARDASIL 9 shot, the patient experienced fatigue; The patient was diagnosed with ADHD , wsa hypostatic when he standed up, and had distractions.; when be eats a heavy meal like pi7..7..a or lots of carbs, be throws up"; This spontaneous report was received from the patient's mother referring to her currently 20 year old male patient. The patient had no medical history, concurrent conditions, concomitant medications, and historical drugs reported.  On an unknown date, the patient was vaccinated with one shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient's mother did not reported an adverse event after her son received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) shot.  Subsequently, approximately in 2017 (reported as"3 years ago"), the patient was vaccinated with three shots of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) recommended by the family physician. The patient's mother reported that starting on the first day the patient received the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot (unspecifed dose number), the patient experienced soreness in his arm (pain in extremity), inflammation at the location of the shot (injection site inflammation), fatigue and headaches. Additionally, it was also reported that on unspecified dates the son was diagnosed with Attention-deficit/hyperactivity disorder (ADHD),  and was hypostatic when he standed up, and had distractions, and when he eat a heavy meal like pizza or lots of carbs, be throwup. The patient seek for medial attention but did not received any treatment for the events.  At the time of the report, the outcome of pain in extremity, vomiting, attention deficit hyperactivity disorder, fatigue, headache and injection site inflammation was reported as not resolved. The report did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Hyperventilation, Syncope
Clinical narrative: the patient fainted after being administered the GARDASIL 9; medical assistant thought the mask and hyperventilating had something to do with the patient fainting; This spontaneous report was received from a medical assistant, referring to an adolescent patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were unknown by the reporter.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (anatomical location was not reported; and route of administration, lot number and expiration date were unknown by the reporter)   On approximately 04-MAY-2020 (also reported as on an unspecified date last week), the patient had an unspecified blood work done right before being vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (anatomical location was not reported; and route of administration, lot number and expiration date were unknown by the reporter).   The patient experienced hyperventilation and fainted (syncope) after being administered the vaccine. The patient had been wearing a face mask and the medical assistant thought the mask and hyperventilating had something to do with the patient fainting. The patient was laid down with their feet up for 20 minutes and recovered.   The causal relationship between the suspect vaccine and the syncope and hyperventilation was not reported.  Upon internal review, the event syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 02-DEC-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered a severe painful rash on her left mid back that radiated around under her arm and under the left breast; diagnosed as shingles (herpes zoster).  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Pt 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Herpes zoster has been considered a disabling event by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: How long do this side effects last; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group adult selected as per vaccine specification.  The reporter asked, how long do this side effects last.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out into hives all over body; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male 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 hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient broke out into hives all over body. After few days, the patient recovered from hives but he was worried about receiving 2nd dose of Shingrix due to allergy concern.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic uti (has had three that lasted about four months).   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced urinary tract infection. On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The consumer reported that his wife received the first Shingrix dose in mid October of last year. He stated that she had not been able to get the second dose because she has had a Urinary tract infection. He stated that they stem from Pseudomonas and Aerobacter and that Bactrim had not worked to resolve her UTIs. Consented to follow up
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Dr. gave me a verbal to give pt his Dtap that was due, he is VFC so I went to get and we did not have any just Dtap but had Dtap and IVP combo.  I asked co-worker if it was ok but she did not ask the age and also let Dr. know that was the only Dtap we had available in VFC, she stated ok to give unsure if she knew about the age recommendation.  I gave the injection and let the parent know that it was the combo.  When I was getting ready to input info I looked under the Dtap/IVP part and it stated Kinrix and I knew that second that I gave the dose that is recommended only for 4 yr old.  I emailed our VFC contact without knowing that she was not at the HD any longer. Made my variance at work and let our VFC contact know what happened and waited until I heard from the HD, I was reminded about by our admin that variance I put in was still opened and so I am now reporting incident
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Bedridden
Clinical narrative: I had all your listed symptoms minus the vomiting / I have a severe reaction to it; I was bedridden for 7 days.; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus (for 46 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced adverse event and bedridden. On an unknown date, the outcome of the adverse event was unknown and the outcome of the bedridden was recovered/resolved.   The reporter considered the adverse event and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that they took their first shot over a couple of months ago. They had a severe reaction to it. They had all company listed symptoms minus the vomiting. The patient was bedridden for 7 days. The patient was due for shot 2. The patient did not know if they should or not take it. The patient was very apprehensive about it. The patient had a question are their reaction considered an allergic reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering
Clinical narrative: reporter blisters in and around her mouth; This case was reported by a nurse via sales rep and described the occurrence of blistering of mouth 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 week after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient reported blisters in and around her mouth within the week of being vaccinated. The reporter was unsure if this would disqualify patient from dose two.  The reporter agreed to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: had an outbreak of herpes; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   The patient's past medical history included herpes virus infection (outbreak of Herpes on July 7 1998).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 10 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The batch number was reported as JRM5J, however it was changed to J3M5J as per sales sheet. The patient provided the NDC number as 5816082901. The patient received Shingrix and had an outbreak of herpes which had not stopped to date. The reporter at the time of reporting need to take the herpes medication for life. On 22nd April 2020, the patient received 2nd dose batch number H4H34, expiry date 27th November 2021 and NDC5816082801. There was no relation between the vaccine and herpes. But the reporter would like to know if there was a relationship between herpes and the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Genital herpes
Clinical narrative: had an outbreak of herpes; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   The patient's past medical history included herpes virus infection (outbreak of Herpes on July 7 1998).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 10 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The batch number was reported as JRM5J, however it was changed to J3M5J as per sales sheet. The patient provided the NDC number as 5816082901. The patient received Shingrix and had an outbreak of herpes which had not stopped to date. The reporter at the time of reporting need to take the herpes medication for life. On 22nd April 2020, the patient received 2nd dose batch number H4H34, expiry date 27th November 2021 and NDC5816082801. There was no relation between the vaccine and herpes. But the reporter would like to know if there was a relationship between herpes and the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering
Clinical narrative: developed blisters inside and around her mouth; This case was reported by a other health professional and described the occurrence of blistering of mouth 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, 1 week after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received dose 1 of Shingrix and 1 week later developed blisters inside and around her mouth. No additional information provided at this time.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dyspepsia, Fatigue, Influenza like illness, Pain
Clinical narrative: indigestion and heartburn; Flu like symptom; achy; chills; tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (on an unknown date the patient received 1st dose of Shingrix refer case US2020AMR074740).   In April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, pain, chills, tiredness and dyspepsia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain, chills and tiredness were recovered/resolved and the outcome of the dyspepsia was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills, tiredness and dyspepsia to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient experienced flu like symptoms (achy, tired, chills) after the 2nd shot for about 36 hours.  The patient also experienced indigestion and heartburn. The patient wanted to know if it was a side effect anyone had experienced. The patient advised to consult physician for the adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: flu like symptoms; achy; chills; tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly 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 influenza-like symptoms, pain, chills and tiredness. On an unknown date, the outcome of the influenza-like symptoms, pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after the first shingles shot the patient had the flu like symptoms (achy, tired, chills) for 48 hours. The patient did not have indigestion the first time. The patient wanted to know if it was a side effect anyone had experienced. For tolerance of 2nd dose refer case US2020AMR074730.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Reaction with Shingrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The pharmacist mentioned that one of their patients experienced reaction with Shingrix.  The reporter was asked what reaction did the patient experienced with the product however she refused to provide it and mentioned that she would contact manufacturer. No additional information was obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 72 hrs after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient development guillain barre syndrome. There was no prior illness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Scratch
Clinical narrative: Scratches on left upper arm; This case was reported by a consumer via call center representative and described the occurrence of scratch in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced scratch. On an unknown date, the outcome of the scratch was not recovered/not resolved.   It was unknown if the reporter considered the scratch to be related to Shingrix.  Additional information was provided as follows: The patient received shingrix in his left upper arm last week and within a week he noticed four scratches on his left arm. He states that they are not rashes, they are scratches, they are not around the injection site, one scratch starts 4 inches below injection site and the others seem to go down his arm and stop at his bicep.  The reporter reported that the scratches did not itch, and nothing was coming out from them. He describes that one scratch was individual, another was separated like a dot that was not full connected and reported that it was possible that he scratched his arm unknowingly and possible that the scratches are unrelated to Shingrix. The reporter did not want this report to be submitted to safety department until he was certain that it was related to Shingrix.  The reporter did not want to be contacted by safety department. The reporter did not consent to follow up. The reporter stated that he changed his mind and did not want this report to be submitted to safety department until he was certain that it was related to Shingrix.  The reporter reported that if he thinks the scratches are significant and related, he would call back to report the adverse reaction.  The reporter did not want to be contacted by safety department.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: pain/ she suffered some localized reactions. The area was painful and swollen.; swollen/ she suffered some localized reactions. The area was painful and swollen.; This case was reported by a nurse via call center representative and described the occurrence of pain localized in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain localized and local swelling. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved.   It was unknown if the reporter considered the pain localized and local swelling to be related to Shingrix.  Additional details were reported as follows: The case was reported by the nurse who reported herself. The patient stated that after her 1st dose of Shingrix, she suffered some localized reactions. The area was painful and swollen.  The reporter did not consent to follow up. This case has been linked with US2020AMR074123, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle twitching, Pain in extremity, Paraesthesia
Clinical narrative: 12AM twitching tingling in legs pain in thighs started 1AM shivering severe by 2AM Had to put blanket in mouth teeth were chattering so badly finally fell asleep or passed out 4AM woke up had to use bathroom light shivering but severe pain in thighs 8AM woke up pain and shivering gone
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Joint/muscle pain (whole body), headache, nausea, shivering - all interfering with sleep, causing frequent waking.  Symptoms resolved by mid morning of following day.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Sleep disorder
Clinical narrative: Joint/muscle pain (whole body), headache, nausea, shivering - all interfering with sleep, causing frequent waking.  Symptoms resolved by mid morning of following day.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Injection site pain, Pallor, Presyncope
Clinical narrative: Near syncope, pale, sweating, severe pain at site for approximately 5 minutes
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came into the office on 4/30/2020 for their well child visit. The patient was due for Dtap. The physician ordered Dtap but Pediarix was given. This unfortunately was not caught until I came back from leave on this week. A physician will be calling  the patient either today or next week to discuss what happened and to answer any questions the parents may have and to determine if the child would need to be re vaccinated. At this time, the parents have not reported any adverse reactions from the vaccine given. My manger is aware of the situation and the employee that is responsible for the error will be counseled.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect reported; a patient was administered an expired dose of PNEUMOVAX 23; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 22-APR-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R002354, expiration date: 17-DEC-2019 (strength, dose number, dosing schedule and route of administration were not reported) for prophylaxis. No additional adverse effect reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse event; inadvertently received first dose of rotateq; inadvertently received first dose of rotateq; This spontaneous report was received from a nurse practitioner referring to a 3 months old patient of unknown gender. Information about patient's concurrent condition, concomitant medication, medical history and drug allergy/reaction was not reported.   On 30-APR-2020, the patient was inadvertently vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) for prophylaxis, lot# S013890, expiry date: 14-FEB-2021 (strength, route, anatomical location was not reported) (wrong product administered and product administered to patient of inappropriate age). No adverse events were reported. No product quality complaint was involved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: diarrhea; fever; leg pain; arm swollen/ swollen arm at injection site; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included peripheral neuropathy. Previously administered products included Shingrix with an associated reaction of pyrexia (for tolerance to the 1st dose refer case id US2020073879).   On 27th April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced diarrhea, fever, leg pain and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the diarrhea, fever, leg pain and injection site swelling were unknown.   It was unknown if the reporter considered the diarrhea, fever, leg pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in right arm and experienced fever, diarrhea, leg pain, and swollen arm at injection site. The reporter stated that she experienced same event after receiving 1st dose which she received 2 months ago from reporting date but symptoms were more severe after dose 2 than 1st dose. The reporter did not consent to follow up. This case has been linked with US2020073879, reported by same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm being a bit sore; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose in December 2019, refer case id US2020073881).   On 28th April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a week 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 reported as follows: The patient received 2nd dose of vacine and experienced a bit arm soreness. There was no other reaction. The reporter did not consent to follow up. This case has been linked with US2020073881, reported by same reporter.
Age: 3.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: administration of Menveo reconstituted with sterile water; administration of Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 3-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA199A, expiry date 30th September 2020) for prophylaxis.   On 11th February 2020, the patient received Menveo (intramuscular) .5 ml. On 11th February 2020, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The health care provider asked for information regarding the administration of Menveo reconstituted with sterile water which led to  wrong solution used in drug reconstitution and inappropriate dose of vaccine administration. The vaccine was not mixed with the correct diluent thereby made the vaccine ineffective, it was unknown which staff mixed (reconstituted) the vaccine. The reporter discovered the error when there was one vial of vaccine left with no diluent. The patient was notified about the error and asked to return for revaccination.  The patient did not report any adverse effects. The patient was agreed to return but did not came till the time of reporting. This case has been linked with US2020036905, reported by same reporter.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation issue, Wrong product administered
Clinical narrative: Quadracel vial for the DTap-Ipv part and mixed it with the ActHIB from the Pentacel, no Ae; patient meant to receive Pentacel but accidentally nurse grabbed Quadracel, No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old female patient who was meant to receive DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number: UJ217ADA and expiry date: 04-Apr-2021) but accidentally nurse grabbed DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] 0.5 ml (lot number: C5688AA and expiry date: 26-Nov-2021)via intramuscular route in the left thigh) vial for the DTap-Ipv part and mixed it with the HIB (PRP/T) VACCINE [ACT-HIB] lot number: UJ217AD and expiry date: 04-Apr-2021) from the Pentacel and this was given on 29-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's past medical treatment included QUADRACEL on 30-DEC-2019 and 02-MAR-2020.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for immunisation.  It was actual medication error due to Inappropriate reconstitution technique and Wrong vaccine administered.   No adverse event reported at the time of reporting.  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.
Age: 0.67
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 8 months old male patient was inadvertently given an expired dose of IPOL vaccine/No AE; Initial information received on 05-May-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves an eight months old male patient who was inadvertently given an expired 0.5ml third dose of IPV (VERO) [IPOL] lot P1A25 , expiry date: 02-MAY-2020 via subcutaneous route in the right thigh on 05-May-2019 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired Act-Hib vaccine/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a patient (age and gender not reported) was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] via unknown route at an unknown administration site (lot number: UJ033AAA and expiry date: 22-Apr-2020) on 23-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: a 9 months old male patient received a combination vaccine with IPV (does not know the name) and also a 0.5 ml dose of Ipol on the same day in April 2020, No AE; Initial information received on 06-May-2020 regarding an unsolicited valid non-serious case received from a other health care professional (medical assistant).  This case involves a nine month old male patient received a combination vaccine with IPV (does not know the name) and also a 0.5 ml dose of IPV (VERO) [IPOL] on the same day (lot number and expiry date: not reported) via unknown route in unknown administration site on an unknown date in Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered.  It was unknown if adverse event occurred or not.  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.  There will be no information on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Ipol was inadvertently administered/NO AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a four years old male patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination.  On 05-May-2020, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot P1A46, expiry date- 03-May-2020) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Injection site erythema
Clinical narrative: I had the 2nd dose of the Shingrix vaccine yesterday (05/07/2020) around 2 PM.  At 2 AM this morning (05/08/2020) I awoke with severe shivering and feeling cold.  The house was warm.  I was in pajamas and had a sheet and blanket.  I had to get out a comforter to get warm enough to go back to sleep.  Awoke at 6 AM this morning with a headache.  My left arm hurts baly when I try to lift it.  It's slightly red and swollen at the injection site.  I feel quite tired.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: I had the 2nd dose of the Shingrix vaccine yesterday (05/07/2020) around 2 PM.  At 2 AM this morning (05/08/2020) I awoke with severe shivering and feeling cold.  The house was warm.  I was in pajamas and had a sheet and blanket.  I had to get out a comforter to get warm enough to go back to sleep.  Awoke at 6 AM this morning with a headache.  My left arm hurts baly when I try to lift it.  It's slightly red and swollen at the injection site.  I feel quite tired.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Client was vaccinated around 09:30. Parent reports child took a nap and when awake, complained of headache, sites on arm were reddened but not over swollen or hot to touch.  Fever of 102 was noted. Parent administered OTC Tylenol alternating with Ibuprofen. Symptoms persisted and  parent called our office to report the situation. I was out of the office on 5/7/20. Today, 5/8/20, I called to f/u with parent. She reports the S/S are subsiding but a low grade temp was still present  this morning.  Parent is confident the girls (twins) will be fine. She asks that we make a notation on chart to be aware when the next Vaccince (Hep A) is administered.  Parent is an RN; she feels that the only new vaccine was the Hep A  that may have caused this as the twins have not had any previous trouble  with vaccines. She plans on continuing  vaccine schedule  as appropriate.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Client was vaccinated around 09:20. Parent reports child took a nap and when awake, complained of headache, sites on arm were reddened but not over swollen or hot to touch.  Fever of 102 was noted. Parent administered OTC Tylenol alternating with Ibuprofen. Symptoms persisted and  parent called our office to report the situation. I was out of the office on 5/7/20. Today, 5/8/20, I called to f/u with parent. She reports the S/S are subsiding but a low grade temp was still present  this morning.  Parent is confident the girls (twins) will be fine. She asks that we make a notation on chart to be aware when the next Vaccince (Hep A) is administered.  Parent is an RN; she feels that the only new vaccine was the Hep A  that may have caused this as the twins have not had any previous trouble  with vaccines. She plans on continuing  vaccine schedule  as appropriate.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Amino acid level, Amino acid level increased, Ammonia, Asterixis, Blood creatine phosphokinase
Clinical narrative: 1 hour post injection of the above vaccines pt had right arm flapping that lasted for around 10 seconds then onset that evening she started having tic/spasm of right head lurching toward right shoulder, right arm would fly up, happen within seconds, appeared similar to infantile spasms; had multiple inconclusive EEGs, placed on delayed vaccine scheduled due to concern for DTAP (pertussis portion per PCP) causing tics/spasms in children; resulted in admit to hospital to epilepsy monitoring unit, MRI brain, labs, seeing neurologist, epileptologist, hematologist, geneticists in total. This workup lasted 3 months.   Outcome: 3-5 months symptoms resolved slowly. No confirmed diagnosis or cause could be found organically.  Labs revealed high MMA, low B12, low iron, normal homocysteine, did not meet criteria for any diagnosis which led to genetics consult with negative Exome testing, still undiagnosed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Blood folate, Blood homocysteine normal, Blood iron decreased, Blood lactic acid, C-reactive protein
Clinical narrative: 1 hour post injection of the above vaccines pt had right arm flapping that lasted for around 10 seconds then onset that evening she started having tic/spasm of right head lurching toward right shoulder, right arm would fly up, happen within seconds, appeared similar to infantile spasms; had multiple inconclusive EEGs, placed on delayed vaccine scheduled due to concern for DTAP (pertussis portion per PCP) causing tics/spasms in children; resulted in admit to hospital to epilepsy monitoring unit, MRI brain, labs, seeing neurologist, epileptologist, hematologist, geneticists in total. This workup lasted 3 months.   Outcome: 3-5 months symptoms resolved slowly. No confirmed diagnosis or cause could be found organically.  Labs revealed high MMA, low B12, low iron, normal homocysteine, did not meet criteria for any diagnosis which led to genetics consult with negative Exome testing, still undiagnosed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Carnitine, Dyskinesia, Electroencephalogram, Full blood count, Gene mutation identification test
Clinical narrative: 1 hour post injection of the above vaccines pt had right arm flapping that lasted for around 10 seconds then onset that evening she started having tic/spasm of right head lurching toward right shoulder, right arm would fly up, happen within seconds, appeared similar to infantile spasms; had multiple inconclusive EEGs, placed on delayed vaccine scheduled due to concern for DTAP (pertussis portion per PCP) causing tics/spasms in children; resulted in admit to hospital to epilepsy monitoring unit, MRI brain, labs, seeing neurologist, epileptologist, hematologist, geneticists in total. This workup lasted 3 months.   Outcome: 3-5 months symptoms resolved slowly. No confirmed diagnosis or cause could be found organically.  Labs revealed high MMA, low B12, low iron, normal homocysteine, did not meet criteria for any diagnosis which led to genetics consult with negative Exome testing, still undiagnosed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Gene sequencing, Laboratory test, Magnetic resonance imaging brain, Muscle spasms, Organic acid analysis
Clinical narrative: 1 hour post injection of the above vaccines pt had right arm flapping that lasted for around 10 seconds then onset that evening she started having tic/spasm of right head lurching toward right shoulder, right arm would fly up, happen within seconds, appeared similar to infantile spasms; had multiple inconclusive EEGs, placed on delayed vaccine scheduled due to concern for DTAP (pertussis portion per PCP) causing tics/spasms in children; resulted in admit to hospital to epilepsy monitoring unit, MRI brain, labs, seeing neurologist, epileptologist, hematologist, geneticists in total. This workup lasted 3 months.   Outcome: 3-5 months symptoms resolved slowly. No confirmed diagnosis or cause could be found organically.  Labs revealed high MMA, low B12, low iron, normal homocysteine, did not meet criteria for any diagnosis which led to genetics consult with negative Exome testing, still undiagnosed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Tic, Vitamin B1, Vitamin B12 decreased, Vitamin B6, Vitamin D
Clinical narrative: 1 hour post injection of the above vaccines pt had right arm flapping that lasted for around 10 seconds then onset that evening she started having tic/spasm of right head lurching toward right shoulder, right arm would fly up, happen within seconds, appeared similar to infantile spasms; had multiple inconclusive EEGs, placed on delayed vaccine scheduled due to concern for DTAP (pertussis portion per PCP) causing tics/spasms in children; resulted in admit to hospital to epilepsy monitoring unit, MRI brain, labs, seeing neurologist, epileptologist, hematologist, geneticists in total. This workup lasted 3 months.   Outcome: 3-5 months symptoms resolved slowly. No confirmed diagnosis or cause could be found organically.  Labs revealed high MMA, low B12, low iron, normal homocysteine, did not meet criteria for any diagnosis which led to genetics consult with negative Exome testing, still undiagnosed.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: ER states that patient came in  alert, but with high fever
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 1 week after vaccine administration