chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: body achiness; fever; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had fever of 101 degree F with body achiness.  No additional information were provided. The reporter did not consent to follow up. This case has been linked with case US2020140195, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140195:same reporter
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Within hours of admin (07/02/2020) of Tdap and Menactra to left deltoid pt experienced pain, stiffness and reduced ROM. This progressed over several days. He was eval'd on 07/06/2020 by NP.  Possible suspected injury to should from vaccine admin since the symptoms had worsened. Seen in follow-up by PCP (myself) 07/30/2020. Cont'd reduced shoulder mobility, pain and PE demonstrating possible rotator-cuff injury.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: discomfort at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had discomfort at the site of injection.  No additional information were provided. The reporter did not consent to follow up. This case has been linked with case US2020140198, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140198:same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Tremor
Clinical narrative: chills; Due to COVID, he has not gotten his second dose yet; shaking; This case was reported by a nurse via call center representative and described the occurrence of tremor in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, chills and social problem. On an unknown date, the outcome of the tremor, chills and social problem were unknown.   It was unknown if the reporter considered the tremor and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced shaking and chills. The patient also reported due to COVID had not gotten his second dose yet. The reporter did not consent to follow up and did not wish to be contacted.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fever; severe headache; severe myalgia; This is a spontaneous report from a contactable physician. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration on 23Jul2020 (last Thursday) at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a 'severe reaction'. The patient developed a fever the next day (on 24Jul2020) along with severe headache and severe myalgia. The fever lasted one day, but the headache had persisted along with severe myalgia and it had been 5 days. He had to take ADVIL 800 mg every 6 hours. The physician would like to know how long the severe headache and severe myalgia will last. The outcome of the event fever was recovered on 25Jul2020. The outcome of the rest events was not recovered.   No follow-up attempts are needed. Information on Lot/Batch and expiration date could not be obtained. No further information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired diluent for ActHIB was used for vaccine administration to a patient, no AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case involves a patient (age and gender not reported) who received 0.5 mL an expired diluent for HIB (PRP/T) VACCINE [ACT-HIB] vial, (Lot Number:UJ112AA, Expiration Date : 21-Jun-2020; Lot Number:UJ112AAC, Expiration Date :21-Jun-2020) once via an unknown route at an unknown administration site for prophylactic vaccination on 23-Jul-2020. It was also reported (Local Trade Name: Act-Hib Lot Number:U6573AD,Expiration Date :2021-03-22)  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication were not reported.  It was an actual medication error due to expired medical agent used (expired product administered). It was reported there was confusion with the expiration dates printed on the vaccines which gave room for misinterpretation thus expired component of vaccine was given.  At the time of reporting, 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 and Module VI of the 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: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted, No AE; Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted, No AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 73 year old male patient who was vaccinated with a 0.5 mL dose DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6603AA and expiry date: 03-May-2022) via an unknown route and administration site for prophylactic vaccination (PT: product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  It was a case of an actual medication error due to incorrect product storage.   It was also the case of product shipment delay.  It was reported that Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3 month old female patient received Quadracel instead of Pentacel, no AE; 3 month old female patient received Quadracel instead of Pentacel, no AE; Initial information received on 24-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a three month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered) (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) ; HIB VACCINE CONJ (TET TOX) (ACT-HIB); and HEPATITIS B VACCINE (HEPATITIS B VACCIN) which were given on 24-Jul-2020 for Prophylactic vaccination.  On 24-Jul-2020, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA and expiry date: 18-Jun-2021) once instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was given an expired dose of Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse and transmitted to Sanofi on 27-Jul-2020.  This case involved an unknown age patient for whom it was reported that a patient was given an expired dose of pentacel with no adverse event (Expired product administered), while patient was received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On 23-Jul-2020the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot: unknown and Expiration date: 22-Jul-2020) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) it was reported that a patient was given an expired dose of pentacle with no adverse event (Expired product administered).  No relevant laboratory data was reported.  Action taken, corrective treatment and event outcome were not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  No further relevant information was reported.
Age: 0.75
Sex: F
Vaccine: IPV, UNK
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received one ml of Tubersol instead of IPOL/No AE; Patient received one ml of Tubersol instead of 0.5 ml of IPOL/No AE; Initial information was received on 27-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a nine months old female patient who on 23-Jul-2020 was tested with 1 mL TUBERSOL (TUBERCULIN TEST) (injection) (lot C5714AA and expiry 10-Jun-2022) via Intramuscular route given in the thigh (unknown if left or right) instead of 0.5 ml of vaccine IPV (VERO) [IPOL] (lot number and expiry date not reported) (wrong product administered, overdose) meant for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Hepatitis B Vaccine for Immunisation.  Case details: It was reported that 1 ml of Tubersol was given Intramuscularly to a patient instead of 0.5 ml of Ipol. Tubersol was administered by a medical assistant. The reporter stated that office will call the mother of the patient.   It was an actual medication error case due to wrong vaccine administered. It was a case of overdose.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient experienced a syncope immediately following vaccination. Episode lasted no more than x10 seconds. Patient was placed in Trendelenberg position, regained consciousness almost immediately and recovered well.  She had not eaten prior to vaccination and was given some crackers and a glass of water.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth at injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Malaise, Myalgia
Clinical narrative: upper arm pain at injection site, muscle and joint pain, feeling of malaise starting on 7/29/2020
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site bruising, Pain, Tenderness
Clinical narrative: Patient reports these adverse effects in/or around injection site after vaccine administration: Bruising for 1 week Numbness of the left thumb for 1.5 weeks Tenderness and pain for 2 months
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, slight cough, sneezes Tylenol I am still aching which is why I said I haven't recovered yet
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Fever, chills, headache, slight cough, sneezes Tylenol I am still aching which is why I said I haven't recovered yet
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Dermatitis, Erythema, Lip haemorrhage, Lip swelling
Clinical narrative: Patient called saying she woke up and touched her lip and it was so swollen that blood spurted out.  She looked in the mirror and her lips were about 3 times their normal size and her skin was red and inflammed.  No other symptoms.  No shortness of breath or hives anywhere else on the body
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: red swollen, taking tylenol, hot to touch
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Kawasaki's disease, Pyrexia
Clinical narrative: Fever 18 days Diagnosed with Kawasaki on 7/29
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Rash maculo-papular
Clinical narrative: Generalized maculopapular rash both arms, chest, abdomen, back and legs.  Seems to be almost completely faded by this afternoon.  Patient is asymptomatic otherwise-no fever, chills, arthralgias or angioedema.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Peripheral swelling
Clinical narrative: PATIENT'S ARM SWELLED AND BECAME RED SOMETIME AFTER INJECTION.  PATIENT CALLED PHARMACY LATER THAT EVENING TO SAY IT WAS A LITTLE PUFFY. SHE KEPT A CLOSE WATCH ON IT AND THEN CALLED HER PHYSICIAN 2 DAYS LATER TO REPORT FURTHER DISCOMFORT
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Woke up the next day with a headache. By noon, terrible chills started and by 4pm, fever of 101.2F and had to go to bed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Rash
Clinical narrative: Patient reports experiencing weakness, rash, and shortness of breath for at least 2 weeks after receiving  the Shringrix vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: We discovered that a patient received only one component of the Menveo vaccine on 7/27/20. The MenA lyophilized conjugate vaccine component was reconstituted with sterile water and administered to the patient.  The patient did not receive the MENCYW-135 liquid conjugate vaccine component.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Eructation, Flatulence, Headache
Clinical narrative: INJECTION SITE DISCOMFORT, GASSINESS, STOMACH PAIN, BURPING, CHILLS, SLIGHT FEVER, HEADACHE, SWELLING ON LEFT MIDDLE FINGER
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Peripheral swelling, Pyrexia
Clinical narrative: INJECTION SITE DISCOMFORT, GASSINESS, STOMACH PAIN, BURPING, CHILLS, SLIGHT FEVER, HEADACHE, SWELLING ON LEFT MIDDLE FINGER
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient reports having a sensitive rash on her left arm, left armpit, and chest areas five days following vaccination.  Her physician, diagnosed her with shingles and prescribed an antiviral medication for treatment.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Limb discomfort, Pain, Paraesthesia, Skin discolouration
Clinical narrative: Patient returned to counter within 10 minutes of receiving vaccination to say her pinky and ring finger on right arm were tingling/stinging.   Called patient later in the evening and she said her finger was slightly discolored, and that her arm was heavy. She said her hand was slightly numb, but that has happened before.  She was advised to go to the emergency room.  She said she would head to urgent care, but she thought it was improving.  She will call us tomorrow with update.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Day after vaccination severe itching began at wrist of injection arm only (thought she was bit by something), progessed from itching to warm sensation and tingling/occasional shooting aches for a few days from elbow to wrist only on injection arm. warm sensation has resolved but 7 days post vaccination still gets occasional shooting/sharp pain sensation from elbow to wrist. No swelling or pain at injection site. No range of motion issues. Felt tired and ran slight temperature for 1 day after.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Day after vaccination severe itching began at wrist of injection arm only (thought she was bit by something), progessed from itching to warm sensation and tingling/occasional shooting aches for a few days from elbow to wrist only on injection arm. warm sensation has resolved but 7 days post vaccination still gets occasional shooting/sharp pain sensation from elbow to wrist. No swelling or pain at injection site. No range of motion issues. Felt tired and ran slight temperature for 1 day after.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Starting approx. 2 hours after vaccination, pt experienced nausea, vomiting, and sweating which has continued over the past 24 hours
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Myalgia
Clinical narrative: Patient had myalgia on both arms and pain in the upper body above belly button
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue, nausea, vomiting, chills
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt reported a red rash going down her arm. Pt denied any pain, itching, or other discomfort. Advised pt that rash is a normal reaction to this vaccine and to continue to self monitor for any changes
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Full blood count normal, Injection site inflammation, Measles antibody negative, Metabolic function test normal, SARS-CoV-2 test negative
Clinical narrative: Injection site was inflamed post injection. 4 days post rash began to spread down his legs and continued to spread over the month and worsened the week of July 20th.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Viral test
Clinical narrative: Injection site was inflamed post injection. 4 days post rash began to spread down his legs and continued to spread over the month and worsened the week of July 20th.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: night of vaccine became ice cold  with  severe shivering then felt very tired, nauseous and  neck and upper back hurt. body felt warm but still shivering in the evening only. Feel rundown. Symptoms still present  3 days later which is day of report.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Skin warm
Clinical narrative: night of vaccine became ice cold  with  severe shivering then felt very tired, nauseous and  neck and upper back hurt. body felt warm but still shivering in the evening only. Feel rundown. Symptoms still present  3 days later which is day of report.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fall, Purulent discharge, Quadriplegia
Clinical narrative: 76 yo AAM PMH including incomplete quadriplegia and long-term abx suppressive therapy for osteomyelitis received Shingrix vaccine dose #2 in R deltoid on 4/24/19. A rash on R hip developed approximately 5 days later. Rash is described as "discrete clusters of purulent appearing blisters on erythematous base" in 7/29 note. Patient's wife also reported he fall on R side prior to rash appearing. Rash now resolved but remains cool to the touch.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 76 yo AAM PMH including incomplete quadriplegia and long-term abx suppressive therapy for osteomyelitis received Shingrix vaccine dose #2 in R deltoid on 4/24/19. A rash on R hip developed approximately 5 days later. Rash is described as "discrete clusters of purulent appearing blisters on erythematous base" in 7/29 note. Patient's wife also reported he fall on R side prior to rash appearing. Rash now resolved but remains cool to the touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain + inflammation on left shoulder (around injection site) Got vaccination on 7/27/2020
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nightmare
Clinical narrative: Pt reported experiencing severe cold/flu like symptoms, she particularly mentioned shivering, for 10 days after receiving vaccine and stated that it triggered a fibromyalgia attack. Pt said she contacted her MD office at time and was instructed how to manage symptoms.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fibromyalgia, Influenza like illness, Nasopharyngitis
Clinical narrative: Pt reported experiencing severe cold/flu like symptoms, she particularly mentioned shivering, for 10 days after receiving vaccine and stated that it triggered a fibromyalgia attack. Pt said she contacted her MD office at time and was instructed how to manage symptoms.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Chills; Headache; Fever; felt so bad; This case was reported by a consumer via call center representative and described the occurrence of chills in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache, fever and feeling bad. On an unknown date, the outcome of the chills, headache, fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the chills, headache, fever and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Batch number and expiry date were not known. The patients experienced chills, fever and headache.  It was reported that some people experience adverse event longer and advised him to follow up with his health care professional if they continue and were bothersome.  The reporter consented to follow up. The case has been linked with the case US2020AMR138539, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR138539:same reporter
Age: 28.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness
Clinical narrative: patient received 2 vaccinations at pharmacy, Gardasil was administered first then the boostrix about 1 inch apart from the first in the same arm per patient request. After vaccination, patient was instructed to sit and take her time before continuing her shopping trip. A few minutes after her vaccine she tried to get up and asked to continue to sit. Patient was encouraged to take all the time she needed. She said she felt dizzy, pharmacist on duty offered water. After about 20 minutes and checking on the patient at 5 minute intervals she said she was not as dizzy but her heart started to feel like it was "beating really fast" and chest started to "feel heavy". At this time the pharmacist offered to call emergency services so she may be assessed appropriately. Patient declined. After about another 5 minutes patient was still sitting so pharmacist offered to call emergency services again. At this time she accepted, emergency was called and medics were dispatched. Upon their arrival medics checked patients vitals. Blood pressure, heart rate, oxygen saturation, heart and lung sounds. All tests reported within normal limits. patient's breathing become more normal. Per medic everything was normal and patient was given option to be transported to hospital but refused. Medics cleared patient. Patient said she was feeling better and ok to go.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Aphasia, Confusional state, Disturbance in attention, Dizziness, Headache
Clinical narrative: I felt confused and lightheaded / trouble focusing. I felt as though my speech was slightly impaired, not quite slurring, but abnormal. I had some difficulty thinking of the right words to say. My gross motor skills were not affected. This period of AMS lasted for around 2 hours, then cleared on its own. I developed an unusual headache afterwards that lasted into the next morning/ day ( I was at work at the time / 3rd shift). I came home from work and slept for 12 hours.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Mental status changes, Speech disorder
Clinical narrative: I felt confused and lightheaded / trouble focusing. I felt as though my speech was slightly impaired, not quite slurring, but abnormal. I had some difficulty thinking of the right words to say. My gross motor skills were not affected. This period of AMS lasted for around 2 hours, then cleared on its own. I developed an unusual headache afterwards that lasted into the next morning/ day ( I was at work at the time / 3rd shift). I came home from work and slept for 12 hours.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test, Gene sequencing, Lumbar puncture, Nerve injury, Seizure
Clinical narrative: Seizures and Neurological damage
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report has been received from a registered nurse, concerning a 5-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided.  On 21-JUL-2020, the patient was vaccinated with  improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Albumin status rha) lot # S027465 with expiration date 02-MAR-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis which was reconstituted with a properly stored sterile diluent. No additional adverse effects were reported.  The vaccine was stored at a temperature between -14 to -10 Celsius degrees which showed -13.1 Celsius degrees and a time frame of 1 hour and 18 minutes with previous temperature excursion of (-9 to 8 Celsius degrees for 8 hours and 25 minutes and, -14 to -10 Celsius degrees which shoed -10.8 Celsius degrees for 6 hours and 30 minutes).Digital Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 23-APR-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider (HCP) for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider (HCP) for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider (HCP) for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional adverse effect were reported; patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 23-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50/1 U/ml (lot # S007265, expiration date 07-JUL-2020), 1 milliliter once for prophylaxis (route and anatomical site of administration were not provided). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, HPV9, UNK
Symptoms: Extra dose administered
Clinical narrative: patient received a total of 4 dose of GARDASIL 9; the patient received a total of 4 doses of Gardasil 9; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 15-NOV-2011, 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) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 10-FEB-2014 and 31-AUG-2014, the patient was respectively vaccinated with the second and the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) (inappropriate schedule of product administration). On 24-JUL-2020, the patient received the forth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1637642, expiration date 28-MAY-2020; dose detail, strength and route were not provided) (extra dose administered). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE was reported; Improperly stored vaccine was administered to a patient; This spontaneous report was received from a medical assistant referring to a 5-year-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 27-JUL-2020, the patient received an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (dosage regimen was not provided) lot # S030093, expiration date 24-MAR-2021 for prophylaxis. The improperly stored dose experienced a temperature of -11.17 degree Celsius (°C) for 19 hours, with a previous temperature excursion of -11.77 °C for 2 hours, and the call was because of a data logger. No additional adverse effects reported.  This is one of 2 cases received from the same reporter.; Sender's Comments:  US-009507513-2007USA010881:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Blindness transient, Dizziness, Syncope
Clinical narrative: The patient got dizzy, lost vision briefly and fainted; The patient got dizzy, lost vision briefly and fainted; The patient got dizzy, lost vision briefly and fainted; Vaccine reported as HPV vaccine; This spontaneous report was received from a consumer who is the patient's mother via company representative, referring to a 11-year-old female patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 14-JUL-2020, the patient was vaccinated with an HPV vaccine (manufacturer unknown) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient also received 4 other unspecified vaccines on the same date however, no information regarding those vaccines was provided.   On the same date, the patient got dizzy (dizziness), lost vision briefly (blindness transient), and fainted (syncope). It was reported that the events were resolved after a few minutes and the patient was fine afterwards.   The causal relationship between the aforementioned adverse events and vaccination with HPV vaccine (manufacturer unknown) or any of the other unspecified vaccines was not provided.   Upon internal review, the events blindness transient and syncope were determined to be medically significant.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010500:
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; the patient was administered a pediatric dose instead of adult dose; This spontaneous report as received from a medical assistant, refers to a 19 year old patient. The patient concurrent conditions, pertinent medical history, allergies or drug reactions were not reported.   On 20-JUL-2020,  the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form,(lot 3, expiration date, route of administration were not mentioned) booster dose for prophylaxis, instead of an adult dose (product administered to patient of inappropriate age)  However, at the time of this report the patient had not presented any adverse event.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported; a patient received a dose of VAQTA (lot S007770 Exp Date 7/24/2020) on 7/27/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.      On 27-JUL-2020, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, 0.5 milliliter, lot # S007770, expiration date 24-JUL-2020,  via unknown route for prophylaxis (Expired vaccine used). No other adverse effects were reported. No product quality complaint (PQC). The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; On 27-JUL-2020 a patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided.  On 27-JUL-2020, the patient was vaccinated with with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered subcutaneously (strength, dose, vaccination scheme frequency, and anatomical site of vaccination were not reported; lot number S031497 has been verified to be a valid, expiration date reported and validated as 07-OCT-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number S038697 has been verified to be a valid, expiration date reported and validated as 10-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 28.4 degrees Fahrenheit for 6 hours and 38 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other Adverse Event reported.; Patient received VAQTA vaccine after expiration date.; This spontaneous report as received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 28-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 0.5 milliliter (strength, route, frequency, and anatomical location, were unknown) with lot # S007769, and expiration date 24-JUL2020 for prophylaxis. No other adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007769; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability