chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Client called on 9/12/19. C/o fatigue, increase temp (100.3), starting on 9/11/19 and going into 9/12/19. She also had no appetite and was "out of it" at times. The swelling of a half dollar coin started on left arm at the injection site growing into a little larger in size and painful to touch. No rash.I explained to her that this is normal per VIS sheet. I instructed her to put a cool compress on it and to take Tylenol or Motrin to help with discomfort. 9/13/19 Called client today. She said that she still has fatigue, but the red spot (injection site) is less red and she can move her arm better. She also said she had some diarrhea during the night, but its probably not from the shot. She is feeling better.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client called on 9/12/19. C/o fatigue, increase temp (100.3), starting on 9/11/19 and going into 9/12/19. She also had no appetite and was "out of it" at times. The swelling of a half dollar coin started on left arm at the injection site growing into a little larger in size and painful to touch. No rash.I explained to her that this is normal per VIS sheet. I instructed her to put a cool compress on it and to take Tylenol or Motrin to help with discomfort. 9/13/19 Called client today. She said that she still has fatigue, but the red spot (injection site) is less red and she can move her arm better. She also said she had some diarrhea during the night, but its probably not from the shot. She is feeling better.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like sxs
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Back pain, Chills, Dizziness, Fatigue, Limb discomfort
Clinical narrative: onset dizziness, fatigue, (L) arm swelling, pain, fever, chills, nausea, muscle pain back, knew, arms, bilat hand tingling, bilat foots discomfort
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nausea, Pain, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: onset dizziness, fatigue, (L) arm swelling, pain, fever, chills, nausea, muscle pain back, knew, arms, bilat hand tingling, bilat foots discomfort
Age: 56.0
Sex: U
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives from #2
Age: 12.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Syncope
Clinical narrative: after an unspecified amount of time the patient fainted; This spontaneous report was received from a physician via company representative, referring to a 12 year old male patient. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot/batch # and expiration date were not provided) for the prevention of Human Papillomavirus (HPV) related disease. During, the same office visit the patient also received a meningococcal conj vaccine (unspecified) (dose, frequency, route, indication, lot/batch # and expiration date were not provided). After an unspecified amount of time, the patient fainted (syncope). The outcome of syncope was unknown.     The causal relationship between syncope and the suspect therapies was not provided.   Upon internal review, the event of syncope was considered to be medically significant.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Erythema, Extensive swelling of vaccinated limb, Induration, Labelled drug-drug interaction medication error, Pain in extremity
Clinical narrative: Rigth arm swollen / right arm with hard bump; Rigth arm red; Rigth arm tender, painful; Rigth arm warm to touch; Labelled drug-drug interaction medication error; vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 7AR35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX6C1AA, expiry date 30th June 2020) for prophylaxis.   On 3rd September 2019, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml and Bexsero .5 ml. On 3rd September 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season and Bexsero, the patient experienced labeled drug-drug interaction medication error and vaccine administered at inappropriate site. On 5th September 2019, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm, skin warm, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown.   The reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm to be possibly related to Fluarix Quadrivalent 2019-2020 season and Bexsero.  Additional details were provided as follows: The patient received dose of Fluarix  tetra and Bexsero in the right deltoid on same day, at same site, which led to labeled drug-drug interaction medication error and inappropriate site of vaccine administration. The reporter stated that, the patient went to urgent care on 5th September 2019 for right arm swollen, red, tender, painful and warm to touch. The  patient follow up on 6th September 2019 at primary care provider for right arm swollen, red, tender and now with hard bump. The patient was seen and treated by provider. There was discrepancy in the suspect reported. The supect vaccine was updated as per sale's data sheet.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Product administered at inappropriate site, Skin warm, Tenderness
Clinical narrative: Rigth arm swollen / right arm with hard bump; Rigth arm red; Rigth arm tender, painful; Rigth arm warm to touch; Labelled drug-drug interaction medication error; vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 7AR35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX6C1AA, expiry date 30th June 2020) for prophylaxis.   On 3rd September 2019, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml and Bexsero .5 ml. On 3rd September 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season and Bexsero, the patient experienced labeled drug-drug interaction medication error and vaccine administered at inappropriate site. On 5th September 2019, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm, skin warm, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown.   The reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and skin warm to be possibly related to Fluarix Quadrivalent 2019-2020 season and Bexsero.  Additional details were provided as follows: The patient received dose of Fluarix  tetra and Bexsero in the right deltoid on same day, at same site, which led to labeled drug-drug interaction medication error and inappropriate site of vaccine administration. The reporter stated that, the patient went to urgent care on 5th September 2019 for right arm swollen, red, tender, painful and warm to touch. The  patient follow up on 6th September 2019 at primary care provider for right arm swollen, red, tender and now with hard bump. The patient was seen and treated by provider. There was discrepancy in the suspect reported. The supect vaccine was updated as per sale's data sheet.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel Vaccine was given to patient on 09/09/19 however, Pentacel was not reconstituted to include HIB. Patient has no signs and symptoms of an adverse event but this is considered an error. Outcome is that we are contacting mom to give HIB portion of vaccine separately.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: R thigh with possible cellulitis. Erythema, induration, warmth up to 4-5cm in length (3cm wide). Started on antibiotics (cephalexin) due to concern of infection. Improving by 9/17/19, but area still palpable on R thigh, not tender.
Age: 10.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site swelling
Clinical narrative: Localized swelling of thigh, increasing over 2 days. Improved within 5 days after immunization.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pt came in with complaint of body rash and pain associated with rash.  She stated that she has not started anything new since the vaccination.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient and husband received flu shot at the pharmacy. The patient went first and then waited in the room while her husband received his vaccine. At that time there were no complaints of feeling dizzy or unwell. About 15 minutes after receiving the vaccine, the patient left the store and passed out, hitting her head on the sidewalk. A nearby customer called 911, and the EMT's were caring for the patient at the time the pharmacist and store manager were notified and made it outside. She was moved to the ambulance and subsequently taken to the hospital where admitted.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient was given her vaccine and seemed fine. She  left the pharmacy area with both of her parents. I followed them to let them know that for the school we may need to print a form for her to show proof of the vaccine. When I turned to go print the form, her mom yelled for help that patient is passing out. We all lowered patient to the floor. I told her dad to call 911. I checked for breathing and she was breathing. I rubbed by her collar bone and said her name for her to wake up(while always having my face by her face checking her breathing)  and after maybe 20 seconds, she woke up. We kept her on the floor for a while. She said that she had nothing to eat all day. He mother then told me that patient passed out when she got her last tatoo. Management brought her an orange juice and 911 checked her out. She said she was fine and they let her go on her with her patents.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient seen and diagnosed with Varicella  without complications on 3/15/2019. Symptoms included rash, on face , torso, arms, for 1 day.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Eye movement disorder, Loss of consciousness, Posture abnormal, Skin discolouration, Tremor
Clinical narrative: * not sure what strand of the influenza was given, my son got his immunizations and shortly after turned gray/white in the face, eyes rolled back and his head dropped, he started to shake and the medical assistant and I helped him down to the ground, the doctor then came into the room, we propped his legs up, his blood went back, color got slightly better, he started to regain consciousness.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Paraesthesia, Rash
Clinical narrative: After immunizaion of prevnar in right arm had numbness and tingling that extended from the right side of her neck all the way down her arm and extending the right torso and down the right low back to the right knee.  Currently aching in the upper arm and numbness from the right shoulder to the right elbow.  The rash is characterized by pain and redness
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: After immunizaion of prevnar in right arm had numbness and tingling that extended from the right side of her neck all the way down her arm and extending the right torso and down the right low back to the right knee.  Currently aching in the upper arm and numbness from the right shoulder to the right elbow.  The rash is characterized by pain and redness
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: she noticed that her arm was itchy so she removed the bandage. then she noticed it was red and slightly swollen on down her arm. It was slightly warm to the touch.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Gait disturbance
Clinical narrative: Fever, shivers, couldn't get warm.  Shivered all night curled into a tight ball trying to stay warm.  I tend to be very warm at night, so shivering from cold on a mild evening was an extreme reaction for me.  Overall body aches and pain, fatigue and weakness.  Could barely walk to the bathroom.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, shivers, couldn't get warm.  Shivered all night curled into a tight ball trying to stay warm.  I tend to be very warm at night, so shivering from cold on a mild evening was an extreme reaction for me.  Overall body aches and pain, fatigue and weakness.  Could barely walk to the bathroom.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling abnormal, Pain in extremity
Clinical narrative: Patient called and spoke with Pharmacist Monday 9/16/19 and told her that she didn't feel good and that her arm was sore.  Today she came in and said that she feels better but her arm is still soar and a little red.  I told her that since she is feeling better than she was yesterday to give it a few more days and that unfortunately this type of reaction is normal.  I told her to watch her arm and that if it starts to hurt more or swell then to go to urgent care or make a dr appointment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Drooling, Lethargy, Lip swelling, Pallor
Clinical narrative: Pt with likely anaphylactic reaction to vaccine given today.  Mom reports pt received vaccines and developed vomiting, drooling, lethargy and swollen lips within minutes of discharge.  On arrival pt appeared pale, was drooling, was sticking his hand into his mouth, and had wheezing on exam.  0.3 mg of epinephrine given and 911 was called.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Pt with likely anaphylactic reaction to vaccine given today.  Mom reports pt received vaccines and developed vomiting, drooling, lethargy and swollen lips within minutes of discharge.  On arrival pt appeared pale, was drooling, was sticking his hand into his mouth, and had wheezing on exam.  0.3 mg of epinephrine given and 911 was called.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Eyelid ptosis, Facial paralysis, Hypoaesthesia
Clinical narrative: 24 hours later she developed R sided facial numbness, that side of her face felt "paralyzed".  She states she has only drooping of her eyelid no other muscle drooping.  Also feels discomfort swallowing.  Sx continue to worsen
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pyrexia
Clinical narrative: Fever, ongoing  nerve pain
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came into the pharmacy on 9/16/19 complaining of redness, soreness, and swelling of his arm. Upon inspection, patient's arm was swollen from shoulder to hands. Pharmacist on duty advised patient to visit an urgent care and get it checked out. The following day, pharmacist called patient to check up. Patient stated he did not end up seeking attention but did take ibuprofen and applied ice to the spot which improved his symptoms greatly.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Red area where injection was given.  Two other raised hives close to the injection site.  Very itchy and sore.  Hives are lightening but the itchiness is still ongoing at 4 days post.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in a normal birth of a full-term infant with no defects.  The subject had not been using contraception prior to becoming pregnant.   On 7 September 2011 at 10:45 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, left arm), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 22 February 2011 and estimated delivery date was 29 November 2011.  Prenatal testing including ultrasounds performed on 25 April 2011 and 12 July 2011, and maternal serum alpha-fetoprotein on 08 June 2011 had revealed no evidence of a defect.  Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 25 April 2011 and 12 July 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 08 June 2011 revealed no evidence of a defect.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included two previous pregnancies resulting in normal births of two full-term infants.  Prior to becoming pregnant the subject had not been using contraception.  On an unspecified date the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  Gestational age at the time of vaccination was unknown.  The conception was reported to be normal.  Date of last menstrual period was 12 January 2011 and estimated date of delivery was 19 October 2011.  Prenatal testing including ultrasound on 29 March 2011 and maternal serum alpha-fetoprotein on 04 May 2011 had revealed no evidence of a defect.   Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 29 March 2011 and maternal serum alpha-fetoprotein on 04 May 2011 revealed no evidence of a defect.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Myalgia, Neuralgia
Clinical narrative: Suspected vaccination failure; Shingles; Warm shooting pains which spread up his back to the should blades; Nerve pain; Muscle pain; welts on neck; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX) for prophylaxis.   The patient's past medical history included chickenpox (the patient experienced chickenpox as a child and then again around age of 32 years).   On 11th April 2018, the patient received the 1st dose of Shingrix. On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received ZOSTAVAX at an unknown dose. In August 2019, between 1 and 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced welts. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, nerve pain and muscle pain. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, welts, nerve pain and muscle pain were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, welts, pain, nerve pain and muscle pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix on an unknown arm (right or left unknown). The reporter did not sure if the injection was in the muscle or just under the skin (subcutaneous) as he did not look at the length of the needle. About a month before the date of reporting (August 2019), the patient noticed welts on his neck. He went to the physician because he thought he might have poison oak. The doctor diagnosed him with shingles. The welts were also on his right shoulder. He was prescribed unspecified antiviral tablets which he took for about a week and the shingles resolved. The patient stated that the shingles outbreak was brief and not bad perhaps because he caught it early. It had fully resolved. The patient also mentioned that occasionally he got warm shooting pains which spread up his back to the should blades. The pain was nerve or muscle pain and was very mild and it came occasionally. It was happening before the shingles outbreak. The patient stated that he had been exercising lately so he was not sure if it could be related to exercising but not had the shingles rash in that area. It was unknown if the reporter considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, nerve pain and muscle pain to be related to Zostavax as well. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Urticaria, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Warm shooting pains which spread up his back to the should blades; Nerve pain; Muscle pain; welts on neck; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX) for prophylaxis.   The patient's past medical history included chickenpox (the patient experienced chickenpox as a child and then again around age of 32 years).   On 11th April 2018, the patient received the 1st dose of Shingrix. On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received ZOSTAVAX at an unknown dose. In August 2019, between 1 and 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced welts. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, nerve pain and muscle pain. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, welts, nerve pain and muscle pain were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, welts, pain, nerve pain and muscle pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix on an unknown arm (right or left unknown). The reporter did not sure if the injection was in the muscle or just under the skin (subcutaneous) as he did not look at the length of the needle. About a month before the date of reporting (August 2019), the patient noticed welts on his neck. He went to the physician because he thought he might have poison oak. The doctor diagnosed him with shingles. The welts were also on his right shoulder. He was prescribed unspecified antiviral tablets which he took for about a week and the shingles resolved. The patient stated that the shingles outbreak was brief and not bad perhaps because he caught it early. It had fully resolved. The patient also mentioned that occasionally he got warm shooting pains which spread up his back to the should blades. The pain was nerve or muscle pain and was very mild and it came occasionally. It was happening before the shingles outbreak. The patient stated that he had been exercising lately so he was not sure if it could be related to exercising but not had the shingles rash in that area. It was unknown if the reporter considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, nerve pain and muscle pain to be related to Zostavax as well. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Fluzone High-Dose was given to a 28 year old that was 22 weeks pregnant/ No AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ238AB, Expiry date-14-Apr-2020 via intramuscular route in the left arm, while she was 22 weeks pregnant on 06-Sep-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was 22 weeks pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  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: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB vaccine that had been reconstituted with sterile water rather than 0.4 % saline, no AE; Initial information and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who received 0.5 ml second dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ055AAA, Exp. Date 20-Apr-2022) via intramuscular route in the right vastus lateralis on 10-Sep-2019 that had been reconstituted with sterile water rather than 0.4 % saline.  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), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was given to a 4 years old male patient/No AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a four years old male patient who received a 0.5 ml fifth dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6401AA, expiry date: 26-Jul-2021 via intramuscular route in the left deltoid on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: pt arm red and painful, reddness starts at upper arm extending to lower arm started Saturday 09/14/2019
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Irritability
Clinical narrative: 9/14: "Mom called stating pt received some vaccines last week and now pt has some redness around the injection site about a quarter size. Mom was concerned that it was more toward the inner thigh. She did notice redness the day of the vaccine. He is not showing any signs of distress related to his heart and is otherwise well. He is on a pulse ox and has has no issues. Mom does feel like his more fussy than normal but she also believes he is getting some teeth. He has had no fever and no breathing difficulty."F 9/16: "Mom called back.  Reports the following: Patient developed a bruise with circumscribed redness to the injection site on the right inner thigh." 9/17: 1 cm x 1.5 cm bruise noted around vaccine insertion site; no redness or swelling noted, skin is not warm to the touch.  Parents have been monitoring.
Age: 43.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the Health Clinic for a TB read on 9/13/19.  She reported to RN that she had received the pneumonia, influenza and TDaP vaccines at store on 9/11/19 following her TB placement.  She stated her right arm which she received 2 vaccines in was red, swollen and warm to the touch from her deltoid and almost down to her elbow.  She stated she had attempted to contact store but did not receive any help.  She stated she had taken some Tylenol and used an ice pack which seemed to help.  She planned to take Benedryl and use ice pack again and she will contact MD if symptoms do not improved or get worse.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given an MMRV and Varicella. So patient received an extra Varicella.
Age: 78.0
Sex: M
Vaccine: FLUA3, HEPA
Symptoms: Confusional state, Dizziness, Fall, Haemorrhage, Head injury
Clinical narrative: Patient received two vaccines.  He was seated as he received the vaccines.  A couple of minutes after he started feeling dizzy.  He sat down but then got back up too soon.  He walked a few steps then passed out.  He fell backwards and hit his head on the floor.  He was bleeding from the back of his head.  He passed out for about two minutes.  He did not stop breathing.  Then he came to but was very confused.  He seemed to be in a lot of pain from his head injury.  911 was called immediately.  He was taken to the hospital.
Age: 78.0
Sex: M
Vaccine: FLUA3, HEPA
Symptoms: Loss of consciousness, Pain
Clinical narrative: Patient received two vaccines.  He was seated as he received the vaccines.  A couple of minutes after he started feeling dizzy.  He sat down but then got back up too soon.  He walked a few steps then passed out.  He fell backwards and hit his head on the floor.  He was bleeding from the back of his head.  He passed out for about two minutes.  He did not stop breathing.  Then he came to but was very confused.  He seemed to be in a lot of pain from his head injury.  911 was called immediately.  He was taken to the hospital.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Malaise, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Patient called pharmacy 3 days post vaccination and reported symptoms of dizziness, leg pain (more clearly described as pins and needles type pain), low grade fever and general malaise. She indicated that it wasn't severe enough for a doctor visit.
Age: 25.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt light headed.  Fainted for a little bit. Patient was ok after a little while.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient presents clinic for mild swelling and pain with a rash in her left upper arm after getting tetanus shot 4 days ago.      States the swelling has improved slightly over the last couple  days but wanted to make sure she was okay. She denies any      fevers or chills. She reports having tetanus injections in the past without reaction. arm and dry; has  erythematous rash of left upper arm 10x14cm marked with skin marker, no induration, or nodules; normal turgor; some warmth to touch, no lymphatic streaking.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Headache, Sneezing
Clinical narrative: strong headache, coughing and sneezing for a week. very low energy.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: After receiving MMR #1 that night he developed severe hives all over his body and face but it  disappeared in the morning . He could not sleep and took Benadryl
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Mumps, Oedema peripheral, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Runny nose, fever, measles/rubella rash over entire body, mumps-swollen neck amd armpit.  Neck is still swollen as of 9-17-19
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Rash rubelliform, Rhinorrhoea, Streptococcus test negative, Swelling
Clinical narrative: Runny nose, fever, measles/rubella rash over entire body, mumps-swollen neck amd armpit.  Neck is still swollen as of 9-17-19
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Body aches, chills, warm, and swollen at site; bruised and red
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, chills, warm, and swollen at site; bruised and red
Age: 1.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Rash
Clinical narrative: Head to Toe Rash. No treatment. went away in 2 weeks.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash erythematous, Rash vesicular
Clinical narrative: Red blistery rash in patches.   Dr. said it resembled shingles, but was spreading to more areas when treated.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions patient fine and tolerated well.  Patient was given a TDAP and a Menveo  before it was due to give.  Mother was informed and aware.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Crying, Feeding disorder, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: about an hour after vaccine administration (at 4:30pm) client began having a fever. Mother medicated with Tylenol. At 6pm the same day child refused dinner and Tylenol didn't break fever. Mother medicated with ibuprofen. child began complaining of stomach pain and inability to eat. At 10pm he complained of neck pain and inability to turn neck. At 2:30 AM on 9.15.19 he began vomiting and crying unconsolably. He was taken to local ER and later released same day. Mother reports when fever drops his stiff painful neck goes way and when fever spikes it hurts again. Highest temp 102.2 F. Client currently managed on Tylenol every four hours and out of school 9.16.19.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Vomiting
Clinical narrative: about an hour after vaccine administration (at 4:30pm) client began having a fever. Mother medicated with Tylenol. At 6pm the same day child refused dinner and Tylenol didn't break fever. Mother medicated with ibuprofen. child began complaining of stomach pain and inability to eat. At 10pm he complained of neck pain and inability to turn neck. At 2:30 AM on 9.15.19 he began vomiting and crying unconsolably. He was taken to local ER and later released same day. Mother reports when fever drops his stiff painful neck goes way and when fever spikes it hurts again. Highest temp 102.2 F. Client currently managed on Tylenol every four hours and out of school 9.16.19.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Eructation, Fatigue, Muscle spasms
Clinical narrative: Donor returned to center on 9/17/19 stating that he started feeling sick to his stomach, weak, nausea, belching, leg spasms, tired and exhausted, and lightheadedness on 9/14/19 around 12:00 pm after receiving the vaccine at 9:29 am on 9/14/19.  Donor stated that this feeling lasted until 9/16/19 around 12:00 pm and that he felt like a million dollars on 9/17/19.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: Donor returned to center on 9/17/19 stating that he started feeling sick to his stomach, weak, nausea, belching, leg spasms, tired and exhausted, and lightheadedness on 9/14/19 around 12:00 pm after receiving the vaccine at 9:29 am on 9/14/19.  Donor stated that this feeling lasted until 9/16/19 around 12:00 pm and that he felt like a million dollars on 9/17/19.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis
Clinical narrative: cellulitis in arm. put on cefadroxil
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Local injection site adverse events : symptoms of redness, swelling, warm to the touch, hardening  or area around injection site occurred about 4-5 hours after receiving the vaccine.  The size of irritation is approximately 2 inches wide. Patient is fine and  had no other adverse events from this particular influenza vaccine.  We put ice on the irritated area and gave one age appropriate dose of motrin.  Two other children siblings received the same vaccine at the same time and they did NOT have any adverse event.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Right arm: swollen, red, hot, hard, pain and  fever for 48 hrs
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Right arm: swollen, red, hot, hard, pain and  fever for 48 hrs
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Dehydration, Fatigue, Injection site erythema, Injection site infection
Clinical narrative: Redness, swelling, pain at injection site. High fever, elevated blood glucose, dehydration, nausea, fatigue. Saw MD, given IM and Oral antibiotics due to infection at injection site. Symptoms still present 7 days later.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Redness, swelling, pain at injection site. High fever, elevated blood glucose, dehydration, nausea, fatigue. Saw MD, given IM and Oral antibiotics due to infection at injection site. Symptoms still present 7 days later.
Age: 83.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Neck pain, Oropharyngeal pain
Clinical narrative: Patient's husband called stating that the patient had neck pain/ throat pain and they think they see the start of a red line.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain
Clinical narrative: Patient complained of "excrutiating pain" followed by difficulty breathing
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site bruising, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: Patient reported "large" swelling around vaccine site, bruising and bleeding "for 2 weeks"
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right lateral upper arm with approx 10cm of well-demarcated circular, erythematous patch that is indurated in the center and slightly warm to touch. No red streaks or fluctuance.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Patient called and complained of increased pain in administration arm. Tried moving arm around but no improvement. nothing done in addition to increase movement noted by patient.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: Patient report severe body ache and severe pain at the injection site. Patient was unable to lie down without feeling pain resulting in insomnia for 2 days,  fever of 100F. He had had shingle before and what he experienced with the vaccine is the exact symptoms of shingle minus the lesions. He felt like the vaccine might had trigger his body to have shingle like symptoms. He was in so much pain that he wanted to go to the emergency room but he did not end up going there. On the third day after the vaccine was administered, patient is feeling a little bit better, no longer having fever but still having residual pain.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Dyspnoea, Pain
Clinical narrative: Patient received Pneumovax and Flu in same arm. Once patient received Pneumovax, stated he was having trouble breathing and chest tightness, which then subsided. He then had lower back pain that was pulsating and radiating across his whole back. I called 911 and EMS was sent to the pharmacy. Patient was alert the whole time. Once EMS came, patients pain was lessening. Vitals taken. EMS and patient felt he was okay to go.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Swelling
Clinical narrative: presenting to clinic for arm pain, redness and swelling - Cellulitis of right upper extremity  Ceftriaxone 250 mg IM injection ordered and given to patient   ?rx written and sent for her to start Keflex 500 mg PO QID for seven days, with food   ?Advised on care instructions for cellulitis and strict ER and return precautions
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: shot recieved to left deltoid - left arm slightly swollen and painful - approx 2cm inderation to injection site
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7:30 pm Client noticed a painful lump at injection site with heat. Client iced 30 min on and off for approx. 3 hours without relief. Client c/o pain all night and disrupted sleep. next morning client c/o all over body aches and joint pain. IBU 800 mg Q6hours on following day with minor relief. Troubled sleep 09/14/2019 with pain. 09/15/2019 entire Lt. arm was hurting more than the rest of her body. IBU taken with no relief. 09/15/19 client slept better. 09/16/2019 full body aches were gone, but left arm still experiencing pain. Pain did not subside until 09/16/2019 in the evening. 09/17/2019 injection site still sore, warm, and swollen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: 7:30 pm Client noticed a painful lump at injection site with heat. Client iced 30 min on and off for approx. 3 hours without relief. Client c/o pain all night and disrupted sleep. next morning client c/o all over body aches and joint pain. IBU 800 mg Q6hours on following day with minor relief. Troubled sleep 09/14/2019 with pain. 09/15/2019 entire Lt. arm was hurting more than the rest of her body. IBU taken with no relief. 09/15/19 client slept better. 09/16/2019 full body aches were gone, but left arm still experiencing pain. Pain did not subside until 09/16/2019 in the evening. 09/17/2019 injection site still sore, warm, and swollen.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot, swollen , aching at injection sight
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. This was just administered to a pediatric patient. Several days worth of follow up calls reported no adverse reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient came into the pharmacy today with a left arm that had redness  of varying degrees in splotches in her left arm between her elbow and shoulder. and said it was because of the shingles shot she had received 18 days earlier. I thought it was possibly infected and recommended that she see her primary care md for treatment. Pt was taking doxycycline, but she said it was for another reason.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Immediate shooting pain in upper arm and shoulder that continues even at rest and has now been 5 hours since injection and there is throbbing pain in left wrist as well. Tylenol and Aleve do not alleviate pain at all. Pain so severe it causes nausea (even before taking any OTC pain relievers).
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Immediate shooting pain in upper arm and shoulder that continues even at rest and has now been 5 hours since injection and there is throbbing pain in left wrist as well. Tylenol and Aleve do not alleviate pain at all. Pain so severe it causes nausea (even before taking any OTC pain relievers).