chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB was reconstituted with sterile water and not with the diluent supplied in the box, no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (may be a toddler) who received HIB (PRP/T) VACCINE [ACT-HIB] (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  Medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution.  It was reported that the ActHIB was reconstituted with sterile water and not with the diluent supplied in the box.  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 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.  Information on the batch number was requested.
Age: 1.58
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 19 month old female received adult Tenivac/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 months old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] for prophylactic vaccination.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate). As per approved recommendation, person from 7 years of age and older must receive this vaccine.  It was reported that no adverse event was noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 19.0
Sex: M
Vaccine: FLU4, HEP, MNQ, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient was in immunizations department when allergies were verified patient only reported penicillin. Patient received varicella vaccine as well Hep B, Flu and Meningococcal vaccine. Shortly after staff member noticed that patient had broken out in hives. Patient then taken to medical assessment department for further treatment where he received epi-pen and Benadryl. Patient afterwards revealed that he had a reaction to varicella in childhood but was not told he was allergic to it.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Diffuse rash all over body including hands and face presenting day 12 following vaccine administration, started overnight and continued to get worse until day 3 . Rash is red, raised and closely spaced, does not seem itchy as child behavior is not scratching.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: Patient started out in Immunizations department. Shortly after receiving varicella vaccine patient did not appear well according to staff member patient was then taken to medical assessment department for evaluation where he received epi-pen and Benadryl. Patient was the transferred  to main hospital for further treatment.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site nodule, Injection site swelling, Joint stiffness
Clinical narrative: Two days after receiving vaccine, patient states she developed severe localized swelling and redness at injection site. Patient reports approximately a 2 inch  "knot" beneath the skin of injection site. Sixteen days after receiving injection, patient noticed joint stiffness in her left middle finger located on the same side of the body in which she received the vaccine. She also noticed bilateral joint pain in both ankles. Patient has been treating with ice pack application to injection site and taking  otc Zyrtec once daily. She was also instructed that she can use otc Benadryl as needed in addition to daily medications. Patient reports improvement of joint stiffness and pain. Patient reports no redness at this time.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: arm sore for 2 days, then severe jabbing pain in head the day after vaccine.  The next day, he had bad headaches when he moved his head.  Then the next day, 4 days after the shot, he got severe shingles rash on shoulder, back, chest
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling, Poor quality sleep
Clinical narrative: Injection very painful originally, pain at site becoming more severe over course of day, by 3:30 pm pain unbearable, felt like I ran into a brick wall, unable to lift my left arm, had to support it at elbow with right hand.  thick swelling at injection site,  chills and fever from 100 degrees to 101 degrees .  I was in bed by 7:30 pm, fitful sleep for most of night. By 6:00 am next morning, no chills, no fever, soreness still in arm, but no longer extreme pain.  Soreness lasted for another day or two.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Injection very painful originally, pain at site becoming more severe over course of day, by 3:30 pm pain unbearable, felt like I ran into a brick wall, unable to lift my left arm, had to support it at elbow with right hand.  thick swelling at injection site,  chills and fever from 100 degrees to 101 degrees .  I was in bed by 7:30 pm, fitful sleep for most of night. By 6:00 am next morning, no chills, no fever, soreness still in arm, but no longer extreme pain.  Soreness lasted for another day or two.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: he developed Shingles
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt was given a normal dose flu on 12/3/2019 and a high dose given on 1/6/2020. NO reactions or symptoms
Age: 18.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Fall
Clinical narrative: 1/24/2020 @ 11:35 am - Administered 7 vaccines to client.  Upon placing sharps into sharps container, the client slid off of chair and fell onto floor.  Awakened client and directed him to sit on chair.  Client alert, sat on chair, and stated he felt dizzy.  Nurses, RN, RN, and NP provided support.  Client drank water, juice, and ate crackers.  Cold compresses applied to right upper front part of face.  Girlfriend was allowed to be present with client's permission.  Waited 15 minutes.  Advised if headache, pressure in head and/or vomiting developed to go to Emergency Room immediately.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Left Arm Pain for weeks.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: 12:15 -pt sitting, vitals taken before admin Gardasil in LA. pt passed out, approx 3 min pt wasn't lucid. vitals taken again, pt friend stated that this is a normal occurrence when pt receives vaccinations.  physician came in and pt was laid down in the floor at this time and her feet were elevated. vitals were taken in increments at this time per physician request, at approx 12:40 pt tolerated sitting up and the pt was wheeled down to the clinic for observation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, chills, aches - flu like symptoms
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PATIENT CALLED STATING SHE WAS NOT ABLE TO WALK YESTERDAY AND TODAY THE INJECTION SITE IS SWOLLEN AND TENDER.  TOLD HER TO TRY PUTTING AND ICE PACK TO HELP WITH THE SWELLING; SEE HER DOCTOR IF IT IS HURTING HER OR GETS WORST.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia
Clinical narrative: Right arm  and Right palm of hand felt  dull sensation of numbness for  about 11 consecutive days. No treatment. Symptom(s) began to decrease one day after 11th day.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site irritation
Clinical narrative: Shingrix was accidentally giving sub-q instead of IM and pt has Redness irritation on injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Rash
Clinical narrative: Rash lower right hip  1 day or 2 days after vaccines. A palmed size then spread to adult hand sized. it was very painful. Pt took Tylenol ant it was relieves, and asaline  but the rash/ painful last for 3 months. Pt did not report to any md/ pharmacist.  Upton today visit, pt wanted 2nd dose of Shingrix and further questions, rph found out about reaction to previous vaccine. Vaccine wasnot given todat.  RX was closed, refunded money to pt .   Allergy to Shingrix was add to profile.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Lethargy, Pain
Clinical narrative: PATIENT EXPRIENCED FLU LIKE SYMPTOMS DAY AFTER THE VACCINE (WEAKNESS, LETHARGY, BODY ACHES) BUT NO FEVER. SYMPTOMS HAVE SUBSIDED.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Lethargy, Myalgia
Clinical narrative: Patient exprienced muscle aches, weakness and felt lethargic. Symptoms have subsided now without further treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction, Tenderness
Clinical narrative: Patient reported red, swollen, sore arm by day 2. Day 3, the swelling and redness was better, still sore to the touch. Getting better with OTC treatment- ibuprofen, ice.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Feeling cold
Clinical narrative: Injection site tenderness started about 6 after injection. 24 hours later feeling tired, fatigued, soreness in arm increased, decreased appetite, feeling cold. 1900 fever of 100.4, nauseated, weak, achy, light headed, bounding heart rate. Temp started to decrease 1 hour after Tylenol.Temp was 98.6 at 2200. Nausea improved after Zofran.  Day 2 after injection- no fever. Still feeling queezy, decreased appetite and weak. Not able to do daily exercise. Not chilling or feeling aches. Right arm - injection site has swelling, flat red linear patches. Tenderness improving. I did have some of these sx with first dose, but this was more severe. Hope this helps.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Injection site tenderness started about 6 after injection. 24 hours later feeling tired, fatigued, soreness in arm increased, decreased appetite, feeling cold. 1900 fever of 100.4, nauseated, weak, achy, light headed, bounding heart rate. Temp started to decrease 1 hour after Tylenol.Temp was 98.6 at 2200. Nausea improved after Zofran.  Day 2 after injection- no fever. Still feeling queezy, decreased appetite and weak. Not able to do daily exercise. Not chilling or feeling aches. Right arm - injection site has swelling, flat red linear patches. Tenderness improving. I did have some of these sx with first dose, but this was more severe. Hope this helps.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Injection site tenderness started about 6 after injection. 24 hours later feeling tired, fatigued, soreness in arm increased, decreased appetite, feeling cold. 1900 fever of 100.4, nauseated, weak, achy, light headed, bounding heart rate. Temp started to decrease 1 hour after Tylenol.Temp was 98.6 at 2200. Nausea improved after Zofran.  Day 2 after injection- no fever. Still feeling queezy, decreased appetite and weak. Not able to do daily exercise. Not chilling or feeling aches. Right arm - injection site has swelling, flat red linear patches. Tenderness improving. I did have some of these sx with first dose, but this was more severe. Hope this helps.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site bruising, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Vaccine was administered on 02/04/2020. Mother of child grew concerns when swelling on site became worst. Appointment was made for 02/05/2020. NP has noticed on site of injection, (left deltoid),  erythema and edema with bruising on top.  Treatment that she has prescribed is Benadryl to reduce swelling and possible antibiotics if swelling becomes larger.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Skin laceration, Syncope
Clinical narrative: syncope for 5 seconds, minor laceration to forehead.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient described having fever, chills, and shooting needle like pain from head to foot for a day and a half following vaccine administration
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Oropharyngeal discomfort, Pain in extremity, Somnolence, Urticaria
Clinical narrative: Patient had throat discomfort several hours after receiving vaccines. Patient was given 1 dose of 25mg Benadryl at Pharmacy. Administering pharmacist followed up with patient on the following day; patient reported feeling better, but groggy from the Benadryl. Today, 2 days after vaccination, patient reports pain and whelps in the left arm (PPSV23) and flu-like symptoms with mild throat discomfort. Instructed patient to take ibuprofen and Benadryl and to follow up with physician in the morning. Instructed patient to go to ER if she feels throat closing or trouble breathing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed herpes zoster one week later
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Hypersomnia, Paraesthesia, Tremor
Clinical narrative: In car on way home, got funny feeling in throat, started tingling right down into my chest and right down just like when you get injected for a catscan except instead of feeling warmth it was a tingling.  Got very shaky.  went in house and called drug store. she said it was an injection reaction and was normal.. As I was talking to her symptoms started to dissipate and I just felt weak..  Laid down for a while..Slept almost all next day
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Child was seen same day at ER, observed. detail medical records not available at this time dad informed us today 2-5 2020
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR
Symptoms: Aspiration, Ear infection, Gait inability, Guillain-Barre syndrome, Immobile
Clinical narrative: rash, fever, ear infection which led to immobility. Paralysis from neck down, consistent with Guillain Barre Syndrome. She was treated with IVIG and has slow but steady improvement - Loss ability to ambulate - Had silent aspiration requiring thickened feed, failed multiple swallow studies - Decrease use of upper extremities, needing assistance feeding herself - Needed inpatient rehab stay, now getting regular PT/OT/Speech therapy, continuing to still need this - Not back to normal self, not yet walking, still improving arm skills
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR
Symptoms: Immunoglobulin therapy, Loss of personal independence in daily activities, Magnetic resonance imaging brain normal, Magnetic resonance imaging normal, Musculoskeletal disorder
Clinical narrative: rash, fever, ear infection which led to immobility. Paralysis from neck down, consistent with Guillain Barre Syndrome. She was treated with IVIG and has slow but steady improvement - Loss ability to ambulate - Had silent aspiration requiring thickened feed, failed multiple swallow studies - Decrease use of upper extremities, needing assistance feeding herself - Needed inpatient rehab stay, now getting regular PT/OT/Speech therapy, continuing to still need this - Not back to normal self, not yet walking, still improving arm skills
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR
Symptoms: Paralysis, Pyrexia, Rash, Swallow study abnormal, White blood cell count increased
Clinical narrative: rash, fever, ear infection which led to immobility. Paralysis from neck down, consistent with Guillain Barre Syndrome. She was treated with IVIG and has slow but steady improvement - Loss ability to ambulate - Had silent aspiration requiring thickened feed, failed multiple swallow studies - Decrease use of upper extremities, needing assistance feeding herself - Needed inpatient rehab stay, now getting regular PT/OT/Speech therapy, continuing to still need this - Not back to normal self, not yet walking, still improving arm skills
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Cyanosis, Electrocardiogram, Hyperventilation, Hypotonia, Pallor
Clinical narrative: Earlier in Evening, Patient was standing in activity center had episode of emesis then became pale. She put her head down with her eyes closing becoming more limp with heavy breathing. EMS called then when they arrived she was at baseline. Then about 5 minutes later she seemed to be sleepy and put head back down again + her upper extremities + hands to finger tips were cyanotic. Mother reports patient has been sick for past few days with URI with (+) sick contacts. Mom reports episode lasting approximately 20 min.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Earlier in Evening, Patient was standing in activity center had episode of emesis then became pale. She put her head down with her eyes closing becoming more limp with heavy breathing. EMS called then when they arrived she was at baseline. Then about 5 minutes later she seemed to be sleepy and put head back down again + her upper extremities + hands to finger tips were cyanotic. Mother reports patient has been sick for past few days with URI with (+) sick contacts. Mom reports episode lasting approximately 20 min.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Severe body pain. Body chills Fever 102'-103 for 48 hours Sweats/after fever broke Injection site redness & swelling Knots on Deltoid muscle
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body pain. Body chills Fever 102'-103 for 48 hours Sweats/after fever broke Injection site redness & swelling Knots on Deltoid muscle
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Muscle fatigue, Paralysis
Clinical narrative: 09/11/2019 Patient received 1st Shingrix vaccine in right arm Lot GL2HR EXP 05/22/2021 11/12/2019 Patient received 2nd Shingrix vaccine in left arm GL2HR EXP 05/22/2021 12/09/2019 Patient is seen at PCP for dizziness and falls 2 to 3 times a week for last 3 weeks 01/31/2020 Patient presented to pharmacy stating that he and his doctor feel that his symptoms of muscle fatigue and paralysis maybe due to the Shingrix vaccines he received.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Antibody test, Differential white blood cell count, Full blood count, Platelet count, Pruritus
Clinical narrative: HIVES, SWELLING, ITCHING TO 90% OF UPPER AND LOWER BODY.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Swelling, Urticaria
Clinical narrative: HIVES, SWELLING, ITCHING TO 90% OF UPPER AND LOWER BODY.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swelling at the injection site; Soreness at the injection site; red circles at injection site; hot at the injection site; headache; fever; Neck was also hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance after 1st dose refer case US2020AMR015667).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at 1 pm and later that evening she experienced swelling and soreness at the injection site. The swelling was the size of a softball. It showed red circles and was hot at injection site. She had a headache and fever and her neck was also hot. The patient could move her arm and neck. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site; Soreness at the injection site; red circles at injection site; hot at the injection site; headache; fever; Neck was also hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance after 1st dose refer case US2020AMR015667).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at 1 pm and later that evening she experienced swelling and soreness at the injection site. The swelling was the size of a softball. It showed red circles and was hot at injection site. She had a headache and fever and her neck was also hot. The patient could move her arm and neck. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Swelling at the injection site; Soreness at the injection site; red circles at injection site; hot at the injection site; headache; fever; Neck was also hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance after 1st dose refer case US2020AMR015667).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, injection site warmth, headache, fever and feeling hot to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at 1 pm and later that evening she experienced swelling and soreness at the injection site. The swelling was the size of a softball. It showed red circles and was hot at injection site. She had a headache and fever and her neck was also hot. The patient could move her arm and neck. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMRV, PNC13
Symptoms: Arthralgia, Pain in extremity, Pyrexia, Staring
Clinical narrative: My daughter got home and said her arm hurt she started getting fever and she went to sleep right away and she didnt wake up until the next day around 6pm she had high fever 105.4 when she woke up she had a blank stare and was not understanding what I was saying I tried speaking to her and she wasn't aware of her surroundings I gave her a bath and she went back to sleep until the next morning I took her for a walk and she said her joints hurt she couldn't walk more that one block for a few weeks. I wasn't aware my daughter could have died. The doctor never told me anything they had planned to give her 5 vaccines in the one visit. I didn't feel comfortable with that. If I would've know vaccines caused it I would've rushed her to the hospital so they could see what they had done to my daughter.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm and shoulder pain lasting 2+weeks
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: Swelling of mouth and lips.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old male patient on 05-FEB-2020.  On 30-APR-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers, but based on follow-up information received (patient's initials, date of birth and gender), this case was determined as valid.  This is one of the several reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Colposcopy, Smear cervix abnormal
Clinical narrative: Pap smear abnormal; This spontaneous report was received from a nurse referring to a 24 years old female patient. Information about pertinent medical history, drug reactions or allergies was not provided. Concomitant therapies included albuterol(VENTOLIN INHALER).    On 02-DEC-2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot # 0597Z, expiration date not reported, but upon internal validation established as 19-AUG-2012) intramuscular for prophylaxis. On 16-FEB-2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot # 0653X, expiration date not reported) intramuscular for prophylaxis.     On 09-DEC-2019, the patient had an abnormal papanicolaou (PAP) test. The patient was referred to another practice for follow up care, where she had a cervical biopsy and a colposcopy. The patient is scheduled for a loop electrosurgical excision procedure (LEEP)  later this month. The outcome of abnormal PAP test was reported as not recovered. Causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: severe and debilitating shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 27-SEP-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(for prophylaxis). Within approximately four to five months of receiving zoster vaccine live(ZOSTAVAX) (in 2014), the patient experienced severe and debilitating shingles requiring extensive medical treatment. These injuries continue today and were caused by zoster vaccine live(ZOSTAVAX).  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, patient 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 Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public.
Sex: F
Vaccine: MMR
Symptoms: Therapeutic product effect decreased
Clinical narrative: Patient experienced poor efficacy (no or low increase in measles titer) after receiving the vaccine.; Patient experienced poor efficacy (no or low increase in measles titer) after receiving the vaccine.; This spontaneous report was received from a consumer via Company representative, reporting on herself, a 67-year-old female patient.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection as prophylaxis (dose, lot number, expiration date, route of administration and site of administration were not reported).  On an unknown date, after the patient received the vaccine, she experienced poor efficacy (reported as "no or low increase in measles titer") (therapeutic product effect incomplete, measles antibody negative). At the time of the report, the outcome of therapeutic product effect incomplete and measles antibody negative was unknown.  The causal relationship between the adverse events and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not experience any symptoms; patient who was between the age of 7.5 to 8 years old was administered one dose of GARDASIL 9; This spontaneous report as received from a physician via company representative refers to a male patient between the age of 7.5 to 8 year old. The patient's concurrent conditions, medical history and concomitant therapies were not reported.        In 2019, the patient was administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose; route, dosage and lot number were not reported) for prophylaxis (product administered to patient of inappropriate age). The patient did not experience any symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Pain, Pneumonia, Rash, Swelling
Clinical narrative: cardiac problem; Pneumonia; significant pain, swelling and rashes across her body.; significant pain, swelling and rashes across her body.; significant pain, swelling and rashes across her body.; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not provided. On 18-OCT-2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Within a week of receiving the vaccination, in October 2017, the patient suffered debilitating injuries including significant pain, swelling and rashes across her body. Within five months of receiving the vaccine, approximately in March 2018, the patient required hospitalization for pneumonia and cardiac problems. According to the reporter, all injuries were caused by Zoster Vaccine Live (ZOSTAVAX). As a result, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the patient's outcome was unknown.  Upon internal review, the event of pneumonia was considered medically significant.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Blindness unilateral, Neuromyelitis optica spectrum disorder
Clinical narrative: optical neuromyelitis / blindness in one eye; This spontaneous report was received from a physician via a company representative, referring to an 11 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.    In March 2019, the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis.  On the same month, the patient was also administered the "TDAP"  and "Meningococcal " vaccines, (strength, dose, route of administration, lot number and expiration date were not reported) also for prophylaxis.  On an unspecified day in September 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).     In November 2019 (also reported as "two months later"), the patient experienced blindness in one eye; the patient sought medical attention and was seen in the emergency department of an unspecified hospital where she was diagnosed with optical neuromyelitis (neuromyelitis optica spectrum disorder).  It was unknown if the patient received any treatment, or if any laboratory test was performed.     On an unspecified date, the patient recovered from neuromyelitis optica spectrum disorder.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), "TDAP"  and "Meningococcal " vaccines and the event.        Upon internal review, neuromyelitis optica spectrum disorder was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENTS; product stroage error; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 13-JAN-2020, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot # S023835 and expiry date 18-MAY-2021, 1 dosage form for prophylaxis (strength, anatomical location, route not reported). The vaccine underwent a temperature excursion (product storage error) prior to being administered to the patient. The time frame for multiple temperature excursions was 32.2 Fahrenheit (°F) 7 hours for 10 minutes. It was reported as no previous temperature excursion was done. Data logger was involved. No adverse effects reported. No product quality complaint was involved in this report.
Sex: M
Vaccine: MMR
Symptoms: Staring
Clinical narrative: had a blank stare; This spontaneous report was received from a physician via company representative referring to a 2 year old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.    On 24-AUG-2017, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, route, lot # and expiry date not reported) for prevention. On an unknown date, the patient had a blank stare for four days (staring). The outcome of staring was unknown. The reporter's causality assessment was not reported.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Swelling
Clinical narrative: She developed cellulitis at the injection site; This spontaneous report has been received from a 48-year-old female nurse, via a company representative, concerning herself. Her current condition included diabetes and her concomitants medications were reported as, 'possibly diabetic medications' (unspecified). Her past medical history and drug allergy or reactions were unknown.   On 31-DEC-2019, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), as prophylaxis (reported as vaccination) (concentration and anatomical location of vaccination were not reported; route of administration, lot number, and expiry date were unknown by the reporter).  That same day,the patient developed cellulitis at the injection site and went to the hospital to seek medical attention where she was administered an epinephrine hydrochloride (EPIPEN). It was unknown if any laboratories diagnostics or studies were performed to the patient. The patient was discharged from the hospital that same day (conflicting information as it was also reported that there was no hospitalization due to the event) with orders to take diphenhydramine hydrochloride (BENADRYL). It was reported that within two days, the swelling began to resolve; and by 30-JAN-2020, the symptoms of cellulitis at the injection site had resolved.   It was reported that cellulitis at the injection site was not considered to be a medically significant, life threatening, disabling, cancerous or overdose event.  The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of cellulitis at the injection site, was not reported.
Sex: M
Vaccine: MMR
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes mellitus; This spontaneous report was received from a consumer referring to his 3.5-year-old son. The patient's pertinent medical history,concomitant medication and drug reactions/ allergies were not provided.     On 17-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rhA, 1 shot, lot # N034411, expiration date 04-DEC-2019; route were unknown) for prophylaxis.        In November 2019 (reported as on or around 17-NOV-2019 to 19-NOV-2019), the patient experienced diabetes mellitus. The patient was therapied with insulin. The outcome of diabetes mellitus was reported as not recovered. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was unknown.  Upon internal review, the diabetes mellitus was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Unspecified patient was administered an improperly stored dose of Varivax; The patient experienced no symptoms; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 03-JAN-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S021320, expiration date 09-JUL-2021 (dose, frequency, route of administration were not provided), for prophylaxis. Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion from -9 to 8 C (-7.11C) for 46 hours. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. The sterile diluent used for the administration was stored properly. The patient experienced no symptoms.  The case is non valid due to lack of the patients' identifiers.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: pain goes around the arm to the inside; feeling hot and swollen at the injection site; feeling hot and swollen at the injection site; Information has been received from a pharmacist via a specialist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 03-FEB-2020, the patient was administrated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency and route were unknown; lot # S002582 and expiration date 10-AUG-2020) for prophylaxis.         On the same day, the patient was experiencing side effects following pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administration, including feeling hot and swollen at the injection site and pain going around the arm to the inside. The outcome of the events were not recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: recently had a blood titer drawn and it was negative for immunity; Information has been received from a consumer referring to a male ptiant of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient never had chicken pox.  In approximately 1995, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were unknown) 2 doses for prophylaxis.    On an unknown date (also reported as recently), the patient had a blood titer drawn and it was negative for immunity. The outcome of the event was unknown. The causality assessment was not reported.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old male patient on 05-FEB-2020.  On 02-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.