chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Fatigue, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient awoke the next morning, 5/22/2019, and could not stand up.  Her legs were profoundly weak, had a difficult time standing up, ambulated very little.  Was not able to get out of the house for at least 3 days following the vaccine.  Numbness was present in her thighs along with the weakness.  The numbness has slowly progressed down the legs and as of today is located around her ankles and feet.  This sensation has left her upper legs as it migrated down the lower extremity.  However, she is still having a very difficult time walking, legs are still profoundly weak and tired.  Difficulty ambulating without holding onto furniture, chairs, etc.  Has never needed any assistive device in walking prior to this.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Patient awoke the next morning, 5/22/2019, and could not stand up.  Her legs were profoundly weak, had a difficult time standing up, ambulated very little.  Was not able to get out of the house for at least 3 days following the vaccine.  Numbness was present in her thighs along with the weakness.  The numbness has slowly progressed down the legs and as of today is located around her ankles and feet.  This sensation has left her upper legs as it migrated down the lower extremity.  However, she is still having a very difficult time walking, legs are still profoundly weak and tired.  Difficulty ambulating without holding onto furniture, chairs, etc.  Has never needed any assistive device in walking prior to this.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Middle insomnia
Clinical narrative: I started feeling pain in my arm about 6 pm the day of the vaccine.  During the night I woke up with body aches.  By morning I had chills, nausea, and severe body aches.  My neck and head hurt a lot- it was hard to move.  My whole body hurt and it was hard to get out of bed.  I was very sick.   By morning I was much improved, mostly weak, slightly achy and nauseas still.  The headache was gone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: I started feeling pain in my arm about 6 pm the day of the vaccine.  During the night I woke up with body aches.  By morning I had chills, nausea, and severe body aches.  My neck and head hurt a lot- it was hard to move.  My whole body hurt and it was hard to get out of bed.  I was very sick.   By morning I was much improved, mostly weak, slightly achy and nauseas still.  The headache was gone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Elevated heart rate began day after shot, 100 bpm all day, second and third day after shot was 89 bpm, and back to normal 69 bpm on fourth day. Fever began around 10:00 am day after shot and lasted about 16 hours. Took 1000 mg Tylenol every 6 hours to treat fever. Skin was uncomfortable to touch on day after shot only. 3"x3" sized red spot on arm at injection site with swelling , very hot,  and pain beginning soon after injection. Has gradually become lighter in color and less swelling but still there here on day 4 after the shot. No pain. A couple of times a day on days 3 and 4 the injection site become quite itchy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain of skin, Pyrexia
Clinical narrative: Elevated heart rate began day after shot, 100 bpm all day, second and third day after shot was 89 bpm, and back to normal 69 bpm on fourth day. Fever began around 10:00 am day after shot and lasted about 16 hours. Took 1000 mg Tylenol every 6 hours to treat fever. Skin was uncomfortable to touch on day after shot only. 3"x3" sized red spot on arm at injection site with swelling , very hot,  and pain beginning soon after injection. Has gradually become lighter in color and less swelling but still there here on day 4 after the shot. No pain. A couple of times a day on days 3 and 4 the injection site become quite itchy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Skin discolouration
Clinical narrative: Upper left arm severe sharp pain; unable to move left arm. And, black/brown blotches on left arm and on face!  Even now in August 2019. What causes this?  Is there any remedy.  No hard feelings, but i should like to know if the issue can be resolved?
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear discomfort, Hypoacusis, Immediate post-injection reaction, Tinnitus
Clinical narrative: Immediate onset of severe tinnitus in both ears that lasted all day for several days.  After two full days the symptoms waned, but then on third day symptoms returned with addition of people's voices having a garbled sound like that of a computer voice modulator at high registers.  Also have added sensation of pressure on the inner ear of both ears similar to being deep under water.  Also, had sensation of ears being 'wet'.  It waned after one day and then came back.  Have experienced continued fluctuating  levels of tinnitus, with ear pressure and distortion of loud sounds and higher pitched tones.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on Left leg, and along Left suprapubic/waistband. Overall Rash improving No treatment needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Broke out in rash on legs and arms over weekend. Spent weekend at grandparents house who have several dogs. Also went fishing and swimming in a pond over weekend. Rash very itchy. No fever. Active and eating well. had kindergarten vaccines 2 weeks ago. Mom states other than swimming in the pond (dad and bother also swam in same pond and are unaffected), the only other exposure is to scabies a couple of weeks ago, and to flea. He stayed with grandparents over the weekend and they have 4 dogs in their home who all have fleas. The animals do not sleep with him while he is there. The rash is extremely itchy and seems to be spreading.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Induration, Mass, Rash erythematous, Skin warm
Clinical narrative: Woke up with a red rash size of a quarter, 2" below injection site. Was hot to the touch. It increased in size to about 3" Round. It had a hard white lump in the middle. I went back to pharmacy. Pharmacist looked at it and said she never saw this before. She called Glaxo who said a rash at inj site is normal. They sent me some reaction paperwork. The rash and lump were gone on Saturday night. I also had a lot of fatigue.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Same As The First Shot This Time in The Left Arm same exact Rash Happed Again in The Same Place on The Right ARM August 6 went To hospital Emergency Room Results Stapled To the Back I need help with This
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Rash vesicular
Clinical narrative: Same As The First Shot This Time in The Left Arm same exact Rash Happed Again in The Same Place on The Right ARM August 6 went To hospital Emergency Room Results Stapled To the Back I need help with This
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dyspnoea, Headache
Clinical narrative: Joint pain, increased shortness of breath Headache.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Extensive Rash over Trunk and exTremities
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: FEVER, CHILLS, ACHING JOINTS.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain in knees & hips. Started the very next day after receiving shot. Had some of these same symptoms after getting 1st shot in Oct 2018, but symptoms much worse with 2nd shot. Still has some aching, but not as severe as it was initially after inj.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Breath holding, Crying, Erythema
Clinical narrative: pt. cried then stopped. held breath, turned red arm and head where loose after aminate pt. cried again.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Gait inability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness, inability to walk on affected leg (Left) Treated for cellulitis with Keflex.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received Shingrix first dose. Next day experienced redness, swelling and pain at site of injection. Two days after receiving dose, the area of swelling increased and continued to experience pain. The patient went to her PCP who prescribed cephalexin for potential infection
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: In May of this year, I got the Tdap Vaccination (Tetanus, Diphtheria, and Pertussis). I have received this vaccination twice in my life and both times it provided an excruciating experience. - The first time (2009), neither I nor my doctor recognized that the symptoms had any correlation to the vaccines. -It was the worst experience I had ever had and since I was on a higher than average dose of Ibuprofen at the time (due to an orthopedic injury), we attributed it to that. -The second time (May 16, 2019) due to advanced technology (smartphones with google) I was able to diagnose the cause - I told my doctor, who had heard this was possible but is supposed to be extremely rare. -My experience from Tdap vaccine May 16, 2019: -I got the vaccine shot about 11:00 am - about 9:00 pm I realized that my body was hurting all over and I had a mild fever (101'F) - similar to if you were sick (fever) and starving (everything hurt) - by 2:00 am my fever had risen to 102.5'F and the body pain was excruciating in every way I can explain - my headache was so bad, I felt like I had a concussion - I was fatigued such that it was difficult to stand/walk - my muscles hurt to the touch and to move - my joints felt like they were very brittle and would snap - my skin felt someone was running a cheese grater over it from every touch (laying in bed was painful) - my cognitive ability was dramatically diminished - my balance bad enough that I had to brace myself while walking to the bathroom - At this time, since I wasn't sleeping anyway, I laid in bed, searched my symptoms, and came across several websites for discussion about these effects of the Tdap - By the next morning, the fever was mostly subsided but all the pain was still there. -I spent the morning at work but was unable to be productive so I left by noon and went home to sleep - Over the next 5 days, my pain symptoms diminished linearly (evenly over each day) - By the 6th day, the pain was mostly gone - I am not aware of residual effects but recognize that if my capacity is slightly diminished that I would not really know. Not exaggerating when I say that it was the most painful/scary experience of my life (both times). Here is a video of another person having the same effects: Unfortunately, neither of my Primary Care Physicians either time (who are both quite knowledgeable and experienced) understood my symptoms. -As Tdap came out in 2005 and my first experience was in 2009, so there was minimal to no data on these side effects. -By 2019 there have been enough cases that it is identified that slight pain and fever are some side effects, but my doctor was very shocked to learn that the side effects could be so bad. -Also, neither of my PCPs knew how to report these events. I found this FDA option after a notable amount of research. I do plan to continue with my vaccinations but will take a different approach next time. -Next time, I will get these vaccines separately (to discover which is the cause), get them each on a Friday (so that I won't have to miss work due to the effects), and to prepare a nest for the weekend (st
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Loss of personal independence in daily activities, Malaise, Oral herpes
Clinical narrative: My daughter got HOV vaccine and has been sick since her injection-2 huge outbreaks of cold sores--missed school
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Dehydration, Gastroenteritis, Intussusception, Pyrexia
Clinical narrative: Small bowel small bowel intussusception with acute gastroenteritis and dehydration with abdominal pain and low grade fever 100.7 .admitted for IVF and observation, repeat US the next day was normal. Pt went home 8/8/19.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Small bowel small bowel intussusception with acute gastroenteritis and dehydration with abdominal pain and low grade fever 100.7 .admitted for IVF and observation, repeat US the next day was normal. Pt went home 8/8/19.
Age: 0.5
Sex: F
Vaccine: HEP, HPV9, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EVENT; WRONG DRUG ADMINISTERED; This report was identified from a line listing obtained on request by the Company from the FDA (VAERS 737236) under the Freedom of Information Act, referring to a 6 months old (reported as 0.5) female patient. The patient was reported to not have any medical history or concomitant medications. The patient's prior vaccinations information was unknown. At vaccination time, the patient was reported to have an upper respiratory infection (URI), which stated on 10-JAN-2018.  On 12-FEB-2018, the patient was vaccinated in private doctor's office or hospital with forth dose of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13), intramuscularly in right leg, hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) intramuscularly in right leg and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by moth (lot number: N010707, expiration date on 03-DEC-2018; dose was not reported), all vaccinations were given for prophylaxis. On the same date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N020352, expiration date on: 10-APR-2020, intramuscularly in the left leg, for prophylaxis) was mistakenly given by staff instead of diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL). It was reported that the patient's mother notified about it 1 hour later, when the mistake was discovered. No known adverse reactions presented at that time (no adverse event). Laboratory studies performed to the patient, if any, were not provided.  The outcome of wrong drug administered and no adverse event was reported as recovered.  Follow up information was identified from a line listing obtained on request by the Company from the FDA (VAERS 737236) under the Freedom of Information Act on 15-APR-2019. This spontaneous report was received from health care professional and refers to a 6 month, not pregnant female patient. The patient has no known drug allergies (NKDA). She was vaccinated on 12-FEB-2018 at 16:00 o'clock and the same time the event happened.  As of 02-AUG-2019. The reporter was unfamiliar with the details of this report. Date of administration of the vaccination was given to the reporter to help in identified the patient and additional details. No additional information collected at the time of this report, Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Nausea, Pain, Pruritus
Clinical narrative: Pain, swelling approximately 3 inches in diameter, redness, hot to touch,  within 12 hours. Increasing pain for another 48 hours and chills and fever of 100.2 . Nausea at 60 hours after that lasted for 8 hours. Localized itching and rash  lasted about 48 hours and started on day 4 after vaccination.  Pain and other symptoms are minimal on day 6 after.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Skin warm, Swelling
Clinical narrative: Pain, swelling approximately 3 inches in diameter, redness, hot to touch,  within 12 hours. Increasing pain for another 48 hours and chills and fever of 100.2 . Nausea at 60 hours after that lasted for 8 hours. Localized itching and rash  lasted about 48 hours and started on day 4 after vaccination.  Pain and other symptoms are minimal on day 6 after.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event, Product dose omission
Clinical narrative: No adverse effects reported; patient missed the following second dose. No additional doses administered; patient missed the following second dose. No additional doses administered; This spontaneous report as received from a pharmacist refers to a 13 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    In May 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL) for prophylaxis.         On 12-AUG-2019, the patient missed the following second dose and no additional doses were administered neither adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Leukaemia
Clinical narrative: an unspecificied female patient was given the GARDASIL Quadrivalent vaccine on an unspecified date and subsequently developed leukemia on an unspecified date over ten years ago; This spontaneous report was received from a physician via company representative referring to a female patient who was in her twenties. Information about her concurrent conditions, pertinent medical history, previous drug reactions or allergies and concomitant medication was unknown by the reporter.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose and frequency were not provided; route of administration, anatomical location, lot number and expiration date were unknown by the reporter). Subsequently, on an unspecified date (reported as over ten years ago), the patient developed leukemia, she sought for medical attention and an unspecified treatment was given. It was unknown by the reporter if any laboratory diagnostic or studie were performed. The patient recovered from the event on an unspecified date, also reported as "she was doing fine".   The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administration and the occurred event, was not provided.  Upon internal review, leukemia was considered to be medically significant.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; a 13 years old patient was administered an expired adult dose of VAQTA; a 13 years old patient was administered an expired adult dose of VAQTA; This spontaneous report was received from a registered nurse referring to a 13 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 14-AUG-2019, the patient was administered an expired adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # R022983 (verified to be a valid lot number), expiration date reported and established as 09-AUG-2019, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnancy; Initial Report Received on 05-Aug-2019  This report was received from the HEPLISAV-B Pregnancy Registry.  A women's clinic reported to a representative that "a couple" of pregnant female patients were administered HEPLISAV-B (hepatitis B vaccine) likely within the last month.    The pregnancies were reported to the registry by the representative.    At the time of the report, no adverse events were reported.   The action taken with HEPLISAV-B was unknown.   Additional information is pending.   Company comment: The company assessed the event of pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B USPI.
Age: 19.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Incomplete course of vaccination, Therapy non-responder
Clinical narrative: teraphy non-responder; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B 1 ml and the 2nd dose of Engerix B 1 ml. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced overdose, adult product administered to child, overdose and adult product administered to child. On an unknown date, the outcome of the overdose, adult product administered to child, overdose and adult product administered to child were unknown.  Additional details were provided as follows: The product and patient identifiers were unknown. The patient received a 1 ml dose for doses one and two of the patient's hepatitis B series, which led to overdose and adult product administered to child.   Follow up information received from nurse on 3rd January 2019: The patient presumably had completed a childhood hepatitis B series and upon going to college had titers tested that were negative which led to Therapy non-responder. The reporter given 2 doses of hepatitis B, it was unsure which brand was used. The patient never followed up for the 3rd dose. If it was Engerix-B, technically,being a booster dose, 1ml was acceptable for this age so it would not be an adverse event. The health care professional never had contact with this invidiual- individual vaccine record was available at the health center and nurse had reviewed it and called GSK with questions about how to handle repeat dosing or  booster for non-responders, should the patient go to their office for dose 3. The patient had yet to be seen.  The health care professional did not want to be associated with the adverse event as it was documented. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypoglycaemia, Hypotension, Local reaction
Clinical narrative: hypotensive; hypoglycemia; dizziness; significant local reaction; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case was linked to 2019SA209617 (same reporter).  This case involves a 11 years old female patient who experienced dizziness, hypotensive, hypoglycemia and significant local reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]); and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  On 26-Jul-2019, the patient received a 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB in the right deltoid.  On unknown date, The patient developed a non-serious dizziness, hypotensive (hypotension), hypoglycemia (hypoglycaemia) significant local reaction (local reaction) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No lab test reported.  Final diagnosis was significant local reaction, hypoglycemia, hypotensive and dizziness.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported..
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: she gave a D.M. a DTaP/IPV from a vial instead of reconstituting with the HIB/no AE; Initial information received on 12-Aug-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves a 7 months old male patient who received only 0.5 ml third dose of DTaP-IPV liquid portion of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) (lot: U6218AA) without the HiB component on 09-Aug-2019 during a Well Check Up. (given Intramuscular in the Left thigh) HIB Lot-UJ015AA, Expiry Date: 26Oct2020, Box- Lot UJ124AAA, Expiry Date: 29Sep2020  Patient's medical history was not reported.  Concomitant therapies were Hepatitis B, Prevnar 13 and Rotavirus given on 09-Aug-2019.  It was of actual medication error due to inappropriate reconstitution technique.   It was reported that no adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of Pentacel on 6-Aug-2019 which was stored at minus 2.6 Celsius for one hour and four minutes, temperature excursion; Initial information and additional information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old patient age unknown was administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 6-aug-2019 which was stored at minus 2.6 Celsius for one hour and four minutes given in error lot number: lC5515AA and expiry date 15-Sep-2019 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event, Product administered at inappropriate site
Clinical narrative: a two months old female patient was given Ipol and Kinrix (Dtap and polio) on 12-Aug-2019; infant was vaccinated in arm; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who was given a 0.5ml dose of IPV (VERO) [IPOL] lot number not reported via intramuscular route in the right arm and KINRIX (Dtap and polio) on 12-aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was an actual medication error due to extra dose administered and Vaccine administered at inappropriate site.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursions/refrigerator door was not closed properly/was at 15.5 degree Celsius for 17 hours 30 minutes; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case involves a 4 years old female patient who received only Pentacel after temperature of vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot number C5560AA), HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (number: C5367AA), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot number: U6153AA), IPV (VERO) [IPOL] (Lot number P1A24MM/ N1K92;) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL) (lot number UI989ACA). The refrigerator door was not closed properly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was of actual medication error due to incorrect product storage. Temperature excursions was at 15.5 degree Celsius for 17 hours 30 minutes.  Pentacel was administered to a patient but it was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: a 22-year-old female patient received an expired dose of Menactra; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case involves a 22 years old female patient who received 0.5 ml single expired dose of MENINGOCOCCAL VACCINE (MENACTRA) (lot: U5839AA, exp date: 05-MAR-2019, via intramuscular route in the Left Deltoid).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications was not there.  It was of actual medication error due to expired vaccine used.  It was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: Parents report the patient had diarrhea for a full week following vaccination.  No fever, apparent abdominal pain, or vomiting reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Nodule, Skin warm
Clinical narrative: Arm is red, hot and large knot. Also felt dizzy all day Sunday and mild headache on Monday. Still red , knot, and hot today.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia
Clinical narrative: head ache, muscle ache, extreme tiredness, upset stomach for one 24 hour period. Tired and upset stomach the next 24 hour period, but able to go to work.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: pain, redness + swelling at injection site; muscle pain in Lt. upper arm (site of injection), area hot to touch, itching at site, fever, shivering, tiredness, malaise, nausea, no vomiting, slight stomach ache, generalized body aches & pains. No treatment. Drank lots of water and herbal tea & soft diet. Did not work for 2 days. Resolved on its own in 3 days. No medical professional seen. (There is no additional information on continuation page.)
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Malaise, Nausea
Clinical narrative: pain, redness + swelling at injection site; muscle pain in Lt. upper arm (site of injection), area hot to touch, itching at site, fever, shivering, tiredness, malaise, nausea, no vomiting, slight stomach ache, generalized body aches & pains. No treatment. Drank lots of water and herbal tea & soft diet. Did not work for 2 days. Resolved on its own in 3 days. No medical professional seen. (There is no additional information on continuation page.)
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: pain, redness + swelling at injection site; muscle pain in Lt. upper arm (site of injection), area hot to touch, itching at site, fever, shivering, tiredness, malaise, nausea, no vomiting, slight stomach ache, generalized body aches & pains. No treatment. Drank lots of water and herbal tea & soft diet. Did not work for 2 days. Resolved on its own in 3 days. No medical professional seen. (There is no additional information on continuation page.)
Age: 81.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Seizure
Clinical narrative: On 8/19/2019 patient reported 2 seizure events occurring since Shingrix vaccination. To note, patient also received Boostrix the day prior to Shingrix vaccine.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Hypotonia, Immediate post-injection reaction
Clinical narrative: Upon administration, patient began to immediately complain of chest pain and slight SOB.  She did not have any rash, swelling, angioedema or lip swelling.  She then began to have a tremor of her bilateral Upper extremities, Left greater than right.  This continued for approximately 10 minutes.  Her vitals were normal other than tachycardia.  She then had multiple events in which she passed out, became limp but responded to verbal stimuli and awoke complaining of similar symptoms.  This persisted for approximately 20 minutes.  At that time, EMS was called.  She was transferred to the nearest ED.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness, Tachycardia, Tremor
Clinical narrative: Upon administration, patient began to immediately complain of chest pain and slight SOB.  She did not have any rash, swelling, angioedema or lip swelling.  She then began to have a tremor of her bilateral Upper extremities, Left greater than right.  This continued for approximately 10 minutes.  Her vitals were normal other than tachycardia.  She then had multiple events in which she passed out, became limp but responded to verbal stimuli and awoke complaining of similar symptoms.  This persisted for approximately 20 minutes.  At that time, EMS was called.  She was transferred to the nearest ED.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Injected limb mobility decreased, Injection site swelling, Pain
Clinical narrative: Pt  c/o severe pain and limited mobility in his right arm.  had temp 0f 102, general body aches and weakness.  there was minimal swelling at the site of injection.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt  c/o severe pain and limited mobility in his right arm.  had temp 0f 102, general body aches and weakness.  there was minimal swelling at the site of injection.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site swelling, Pyrexia, Rash
Clinical narrative: rash, swelling to thigh, fever
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Rash erythematous, Vaccination site pain, Vaccination site reaction
Clinical narrative: Had a red rash below where the vaccine was given and also had severe arm pain that radiated into the shoulder. could not raise the shoulder for about 2 days and could not rub the skin as it was that sensitive to the pain
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neuralgia, Paraesthesia, Skin reaction, Temporomandibular joint syndrome
Clinical narrative: vertigo; fifth cranial nerve pain; headache; TMJD; pinched nerve sensation in the maxillary and facial areas; possible skin reaction; This case was reported by a physician via call center representative and described the occurrence of vertigo in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 10 days after receiving Shingrix, the patient experienced vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction. On an unknown date, the outcome of the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction were recovering/resolving.   It was unknown if the reporter considered the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for himself. The age at vaccination was not reported, but it could be 81 or 82 years. The patient experienced vertigo, fifth cranial nerve pain (including a pinched nerve sensation in the maxillary and facial areas), headache, and a possible skin reaction in the same area. The symptoms were improved, but till the time of reporting, they were not resolved. The reporting physician was given a dental device for temporomandibular joint dysfunction (TMJD) after seeking dental attention. The reporter consented to follow up. The reporter permitted for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: vertigo; fifth cranial nerve pain; headache; TMJD; pinched nerve sensation in the maxillary and facial areas; possible skin reaction; This case was reported by a physician via call center representative and described the occurrence of vertigo in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 10 days after receiving Shingrix, the patient experienced vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction. On an unknown date, the outcome of the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction were recovering/resolving.   It was unknown if the reporter considered the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for himself. The age at vaccination was not reported, but it could be 81 or 82 years. The patient experienced vertigo, fifth cranial nerve pain (including a pinched nerve sensation in the maxillary and facial areas), headache, and a possible skin reaction in the same area. The symptoms were improved, but till the time of reporting, they were not resolved. The reporting physician was given a dental device for temporomandibular joint dysfunction (TMJD) after seeking dental attention. The reporter consented to follow up. The reporter permitted for follow-up.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Injection site swelling
Clinical narrative: sever swelling at injection site; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported similar event for 3 patient. This is 1st of three reports.   A patient of unspecified age and gender started to receive meningococcal group b rlp2086 (TRUMENBA) , via an unspecified route of administration on an unspecified date at single dose for immunisation in the arm, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) , via an unspecified route of administration on  an unspecified date at single dose for immunisation in the same arm.  The patient medical history and  concomitant medications were not reported.  The patient experienced sever swelling at injection site  on an unspecified date with outcome of unknown.  The reported event was considered non serious.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019352013 same reporter/ drug/ AE, different patient.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness and swelling on the upper right arm; redness and swelling on the upper right arm; This is a spontaneous report from a contactable pharmacist (patient's parent) received via a sales representative. A male patient of an unspecified age started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on the upper right arm on an unspecified date. Events took place after use of product. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Posture abnormal, Syncope
Clinical narrative: Patient received HPV vaccine, then MCV4, and lastly the Tdap. Patient remained seated, as nurse was assessed how he was feeling. patient stated he felt fine, but then  fell forward onto  his lap. Nurse laid him back on to exam bed. Patient was alert with in a few seconds. Father stayed with patient while nurse asked provider to assess patient. Dr. assessed patient, and getting vitals. Instructed patient to drink at least 8 glasses of water today, some water and juice before leaving the clinic today. Patient drank water and juice then stood and walked while nurse observed. Patient and father felt confident that they were ready to go. patient left after15 minutes post syncope episode.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Visual impairment
Clinical narrative: patient felt dizzy and lightheaded within a few minutes of receiving the vaccine.   She also claimed she had trouble with her vision.  She stayed seated in a cool room for about 10 minutes and the symptoms passed.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Per pt's mother pt developed a rash and fever that lasted for 2 days,  3 days after receiving vaccines on 05/20/2019. Mom notified office of reaction  on 08/13/2019.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: REDNESS AND WARMTH AROUND SITE
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inflammation, Laboratory test, Pain, Pruritus
Clinical narrative: INFLAMMATION BILATERAL ON BACK, LEFT SIDE AND NECK, RASH ON FRONT CHEST RIGHT SIDE.  RAHS, ITCHING, DULL PAIN AND SENSITIVE AREA.   DIAGNOSED AS SHINGLES BY PA
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Sensitive skin, Skin graft
Clinical narrative: INFLAMMATION BILATERAL ON BACK, LEFT SIDE AND NECK, RASH ON FRONT CHEST RIGHT SIDE.  RAHS, ITCHING, DULL PAIN AND SENSITIVE AREA.   DIAGNOSED AS SHINGLES BY PA
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Terrible headache, fever, joint pain, muscle pain, kidney pain, severe fatigue, but unable to sleep, due to how awful I feel. Shivers, dizziness, light headed. Loss of appetite,  unable to do "normal" daily activities.  Severe pain in injected arm. This was my 2nd vaccination.  The first one was not nearly as awful as the 2nd one.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Terrible headache, fever, joint pain, muscle pain, kidney pain, severe fatigue, but unable to sleep, due to how awful I feel. Shivers, dizziness, light headed. Loss of appetite,  unable to do "normal" daily activities.  Severe pain in injected arm. This was my 2nd vaccination.  The first one was not nearly as awful as the 2nd one.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Renal pain
Clinical narrative: Terrible headache, fever, joint pain, muscle pain, kidney pain, severe fatigue, but unable to sleep, due to how awful I feel. Shivers, dizziness, light headed. Loss of appetite,  unable to do "normal" daily activities.  Severe pain in injected arm. This was my 2nd vaccination.  The first one was not nearly as awful as the 2nd one.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: I had a headache and muscle aches on Sunday.  Today, August 20th, I still have pain, redness and swelling at the sight of the injection.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: PT described feeling sick x3days including shivers/chills, fever. Then felt off the next 2 weeks including fatigue. It went away after that.
Sex: M
Vaccine: TDAP
Symptoms: Brain injury
Clinical narrative: permanent brain injury; This case was reported by a consumer via interactive digital media and described the occurrence of brain injury in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced brain injury (serious criteria GSK medically significant). On an unknown date, the outcome of the brain injury was unknown.   It was unknown if the reporter considered the brain injury to be related to DTPa vaccine.  Additional details were provided as follows: The patient's parent reported the case. The age at vaccination was not reported. The reporter was frustrated and stated that, it was better to have few weeks of coughing to the patient than the lifetime suffering due to permanent brain injury.