chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: 9.5. - received varicella vaccine in L arm, some redness, warmth 9.6. - site with increased redness, swelling and itching at site, took benadryl 9.7 - underside of L arm was red swollen, hot and had a lump, was seen at urgent care and given script for prednisone and told to take for several days if symptoms were no better 9.8. - symptoms were no better so starting taking prednisone, states symptoms were better that evening.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with swelling and redness of about 8cmx 8cm in diameter, where flu shot had been administered. Warm to the touch. Treated with 500mg PO BID for 10 days
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness, Influenza like illness, Middle ear effusion, Nasopharyngitis
Clinical narrative: I'm a seventy year-young male. My complaint is that within 48-hours of the injection, I incurred a hearing loss of at least 3db of sensitivity as a direct result of symptoms similar to the actual contraction of a cold or flu virus; that is, the experience of or the actual fluid accumulation in the inner ear. As of today, 10/22/2019, I still have the symptoms. Indeed, I was never provided a written warning of the latter side-affect by the pharmacist who performed the injection. In a follow-up telephone discussion with my personal physician's RN assistant, she stated that the hearing loss and inner-ear fluid accumulation are temporary. I was glad to hear that because currently I have the attitude that I was injected with poison and am somewhat angry that I was not warned of the possible side-effects of the High Dose option I was injected with. In all of the previous years of October/November flu inoculations, I have never experienced cold or flu symptoms; and probably because I was administered a standard dose on previous occasions.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Bedridden, Body temperature increased, Chills, Dizziness, Malaise
Clinical narrative: Four hours after the injection, my wife was complaining of sever aching and dizziness, then she bagan to shake uncontrollably with chills. I put her to bed and took her temperature. 102.5. We used ibuprophen ,Tylenol , and cold compresses to bring the temperature down. She finally was able to fall asleep . The next morning, we were both pretty ill ( I had gotten the flu vaccine also, and had come down with the same symptoms, only in the middle of the night) and had to remain bedridden pretty much until this morning.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Tremor
Clinical narrative: Four hours after the injection, my wife was complaining of sever aching and dizziness, then she bagan to shake uncontrollably with chills. I put her to bed and took her temperature. 102.5. We used ibuprophen ,Tylenol , and cold compresses to bring the temperature down. She finally was able to fall asleep . The next morning, we were both pretty ill ( I had gotten the flu vaccine also, and had come down with the same symptoms, only in the middle of the night) and had to remain bedridden pretty much until this morning.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Pt reported today with small hives and redness around the area of her vaccine which was received about 5 days ago. she stated it was sore and hot to the touch. She reported no other problems and stated after the vaccine she had no problems just this morning on day 5 reported the side effects and showed us in the pharmacy.
Age: 8.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPAB
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site irritation, Injection site pain, Injection site reaction
Clinical narrative: Guardian stated patient complained of having more pain than usual, and irritation and burning sensation to the vaccine injection site immediately following vaccine administration. Guardian also stated patient has complained on different occasions about irritation and burning to the vaccine site.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site reaction, Pain in extremity, Yellow skin
Clinical narrative: Patient displayed yellow/blue bruise at site of injection. Stated his arm was sore for a few days after injection but did not notice bruise until 10/21
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site rash, Rash
Clinical narrative: Per pt, after 12 hours she developed a rash around the injection site and around her neck. Patient took Benadryl OTC and that seemed to help. A few days later patient started getting random rashes in both arms. On 10/21/19 patient came to the pharmacy and showed a quarter-size rash on the opposite arm below the elbow. There is still a small red area around the neck. Injection site does not bother her.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came by the pharmacy 3 days after Shingrix and Fluzone HD were given Saturday. States the redness and slight swelling and warmth was spreading from injection site in her upper right arm down to her elbow.  She said she has no other symptoms. I recommended she use ice and Benadryl if needed and contact her doctor. She said she feels fine and that she is just visiting for a couple weeks and it is too difficult to contact her doctor. I told her to at least monitor and seek medical attention if it gets worse even after doing the above. She did not seem too concerned, just showing us her reaction.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Nausea, Pyrexia, Renal pain
Clinical narrative: About 10 minutes after receiving vaccine, patient experienced severe lower back pain that she described as kidney pain. She rested for about 10 more minutes and the pain went away. After getting adjusted at home, the pain started again, along with nausea/vomiting, chills/fever. Patient says this lasted about 3 days. She came back into the pharmacy to report those symptoms on 10/22/19.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: About 10 minutes after receiving vaccine, patient experienced severe lower back pain that she described as kidney pain. She rested for about 10 more minutes and the pain went away. After getting adjusted at home, the pain started again, along with nausea/vomiting, chills/fever. Patient says this lasted about 3 days. She came back into the pharmacy to report those symptoms on 10/22/19.
Age: 74.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu vaccinations within a month of each other. Patient attended an off-site clinic and received her flu shot there, then came into the store approxmately a month later, requested and received a second flu vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: 10/09/19 Mother noticed slight redness at injection site on left upper arm around 8pm. 10/10/19 in the AM arm was a little redder and swollen, no fever. Mom sent child to school. Around 2PM school called mom to pick up child because they felt child was having an adverse reaction. Family members brought child to HU for nurse to assess. Reaction measured around 6x6 inches. Left upper arm visibly swollen compared to right arm.Redness and swelling covered whole upper arm from shoulder to elbow and was all the way around the arm. Area was hot to touch. Child had fever of 100F. Called Dr PCP and he saw child 10/10/19 and diagnosed adverse reaction and had mom take child to ER for evaluation and treatment. Mom could not remember ER doctors name. Mom thinks child received a steriod injection and benadryl injection at ER. Child released from ER alternate OTC Zytrec & benadryl. Mom states child is doing good and no redness in arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: I experienced pain in left shoulder radiating down to waist and up to neck and nausea.  The upper arm was hot  and swollen but not red. It was difficult to sleep and I could not rest on my left side or roll over.  I could not raise my left arm for about 36 hours.  About 48 hours from onset I was able to work but had limited range of motion in the left shoulder and upper arm.   Fourteen days later I have a full range of motion but am still taking Tylenol for continuing pain in the upper arm and shoulder.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Neck pain, Pain
Clinical narrative: I experienced pain in left shoulder radiating down to waist and up to neck and nausea.  The upper arm was hot  and swollen but not red. It was difficult to sleep and I could not rest on my left side or roll over.  I could not raise my left arm for about 36 hours.  About 48 hours from onset I was able to work but had limited range of motion in the left shoulder and upper arm.   Fourteen days later I have a full range of motion but am still taking Tylenol for continuing pain in the upper arm and shoulder.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Flu symptoms occurred - aching body, low fever, light congestion, headache, sore throat
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Flu symptoms occurred - aching body, low fever, light congestion, headache, sore throat
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, headache
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Throat tightness, Wheezing
Clinical narrative: Wheezing, Light headed, throat felt like tightening within 15 minutes of receiving vaccine.  Epi pen given, Benadryl 50 mgm.  Felt better after 10 minutes.   Patient requested to take Xanax .5 mgm.  NP approved.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Ear pain, Increased upper airway secretion, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Within 3 hours, my throat swelled up and hurt; I could not swallow; my ears hurt; mucus developed at the back of my throat; I threw up in the ER; the symptoms began to subside after 4 hours in the ER.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Within 3 hours, my throat swelled up and hurt; I could not swallow; my ears hurt; mucus developed at the back of my throat; I threw up in the ER; the symptoms began to subside after 4 hours in the ER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Injection site swelling, Pain
Clinical narrative: Immediate sore and swollen arm.  Approximately 28 hours after vaccine, slight fever, chills, achy - this lasted only a few hours and I would say this was mild.  Swollen, tender area of arm where the injection was given persists almost a week later - although not as bad as first couple of days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Immediate sore and swollen arm.  Approximately 28 hours after vaccine, slight fever, chills, achy - this lasted only a few hours and I would say this was mild.  Swollen, tender area of arm where the injection was given persists almost a week later - although not as bad as first couple of days.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Patient said that her arm has been going numb for short periods of time since she received this vaccine. She says that both of her shoulders are sore sometimes but this doesn't happen in her right arm. Her doctor has had her do stretches so far according to the patient.
Age: 76.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Cellulitis, Dyspnoea, Injection site swelling, Intensive care
Clinical narrative: PATIENTS WIFE CAME TO PHARMACY ON 10/22/19 AND SPOKE TO RPH REGARDING ADVERSE REACTION THAT OCCURRED AFTER RECEVING VACCINES ON 10/17/19. PATIENT REPORTED SWELLING ON RIGHT ARM WHERE 2 VACCINES WERE GIVEN AND REPORTED TO HOSPITAL WITH SHORTNESS OF BREATH. CELLULITIS WAS SUSPECTED AND PATIENT WAS ADMITTED TO ICU FOR 2 DAYS, THOUGH SAFELY DISCHARGED.  IT APPEARED FROM A PHOTO THAT VACCINES WERE CORRECTLY SPACED >1" APART,
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema mild on Left upper Arm w/Edema
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound scan, Vomiting
Clinical narrative: 10/18/19 vomiting 10/19/19 dg with intussusception improved with air enema
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 16-AUG-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions.  Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation (date unknown), the patient was treated by a physician for shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: feels very sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 13th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: This case was reported by the reporter for her friend. The age at vaccination was not reported. The patient received a Flulaval vaccination two days ago and felt very sick. The patient stated that the event was resolved. The reporter did not consent to follow-up. No other information was received. This case has been linked to the case US2019187020, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Skin warm
Clinical narrative: rash; Warm to touch; fever; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received Shingrix. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and skin warm. In October 2019, the patient experienced fever. On an unknown date, the outcome of the injection site rash, skin warm and fever were unknown.   It was unknown if the reporter considered the injection site rash, skin warm and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. Right after receiving the Shingrix, the patient experienced rash on the vaccinated arm, the day after. Warm to touch appeared quickly a day after vaccination. Less than 2 weeks after vaccination, the patient experienced fever of 105 Fahrenheit. The reporter did not know how accurate that temperature was. The rash was worst on the first day and had gotten smaller by the time the patient went to the pharmacy on the 2nd or 3rd day. The reporter was unable to provide full details. The reporter did not consent to follow up. Time to onset for rash had been considered precisely in this case instead of immediately as it seems a general statement and there was a discrepancy in 2 source documents. This case is for 1 of the 3 patients, reported by the same reporter.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia, Rash, Urticaria
Clinical narrative: rash on right arm; hives on right arm; achiness; low grade fever; This case was reported by a nurse via call center representative and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date 30th September 2020) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (received 1st dose on 19th April 2019, refer case US2019143941).   On 16th August 2019, the patient received the 2nd dose of Bexsero. On 17th August 2019, 1 days after receiving Bexsero, the patient experienced fever, rash, hives and pain. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, rash, hives and pain were recovered/resolved.   It was unknown if the reporter considered the fever, rash, hives and pain to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and next day he broke out in a rash and hives down his right arm which got worse for 2-3 days, he had a low grade fever, and was achy for 48 hours. All events have resolved. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Big, hard knot where vaccine was given. Also red and warm.; Big, hard knot where vaccine was given. Also red and warm.; Big, hard knot where vaccine was given. Also red and warm.; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 12-month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient had a big, hard knot where vaccine was given, it was also red and warm, the events took place after the use of the product. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 61.0
Sex: U
Vaccine: PNC13
Symptoms: Lung disorder
Clinical narrative: lung issues; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A 62 years old patient of unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) when 61 years old, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lung issues on an unspecified date with outcome of unknown. It was not clear if the lung issues were before the pneumococcal 13-val conj vac (dipht crm197 protein). The reporter said the patient has lung issues and the doctor reordered for the patient to get the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine again and the caller thought the patient should get the Pneumococcal 23.  Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: mild fever; drowsiness; This is a spontaneous report from a non-contactable consumer.   A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild fever and drowsiness on an unspecified date, within a few hours of receiving the vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: IPV, MMR, TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Ipol was given on 09-Oct-2019, later discovered that it had expired on 05Oct2019, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 39 yerars old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (frequency once) lot N1J451M, expiry date: 05-Oct-2019 unknown route in the left deltoid on 09-Oct-2019.   The patient's past vaccination(s) included IPOl which she recieved as child.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It is an actual medication error case due to expired vaccine used.  It was reported that Ipol was given as a booster dose for a patient with unknown childhood immunization history, but who stated that she did receive vaccination for polio as a child. The nurse said that she would therefore consider this dose as 3 and the patient was administered on 10/09/2019 with IIPOL that expired 10/05/2019.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea
Clinical narrative: 6 episodes of diarrhea; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who experienced 6 episodes of diarrhea (diarrhea), while he 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.  On 11-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 14-Oct-2019, the patient developed a non-serious 6 episodes of diarrhea (diarrhoea) 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was 6 episodes of diarrhea.  It was not reported if the patient received a corrective treatment.  The outcome of the event was Unknown.  Information on the batch number was requested.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the HIB portion of the powder that gets reconstituted was not given, but only the d-tap portion of the Pentacel/No AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received only DTAP (DIPHTHERIA, TETANUS and ACELLULAR PERTUSSIS) portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ7AAA, expiry date- 19-sep-2020 third dose via unknown route in right thigh on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  The HIB portion of the powder that gets reconstituted was not given, but only the DTAP portion of the Pentacel.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: they gave a patient expired (June 30, 2019) Fluzone Quadrivalent 0.5ml, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 91 years old male patient who received a0.5 ml dose of expired vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ005AC, expiry date: 30-Jun-2019 via intramuscular route in the deltoid NOS on 15-Oct-2019.  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 expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel that was 4 days expired administered to a patient, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was inadvertently vaccinated with an expired 0.5 mL second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) lot C5552AA, expiry date: 14-Oct-2019 via intramuscular route in left thigh on 10-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: started getting SOB, difficulty getting air in; throat was closing up; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 71 years old female patient started getting SOB, difficulty getting air in (dyspnoea) and throat was closing up (throat tightness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Cardiac operation and Dyspnoea. The patient's past vaccination(s) included Fluzone in 2018, Flucelvax in 2015 and Fluarix. The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Diabetes mellitus and allergic to aspirin and contrast dye (Her throat usually closed up with those).  On 14-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient started getting SOB, difficulty getting air in (dyspnoea) and throat was closing up (throat tightness) one hour 30 minutes  following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.      Final diagnosis was dyspnoea and throat tightness.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from the events.  Information on the batch number was requested.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Erythema, Headache, Joint swelling, Pain
Clinical narrative: severe pain, random rotating pain; erythema; swelling in joints; hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter; scalp tenderness; confusion; frequent urination for 10 days; headaches; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 82 years old male patient who experienced severe pain, random rotating pain (pain), erythema (erythema), swelling in joints, hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter (joint swelling), scalp tenderness (pain of skin), confusion (confusional state), frequent urination for 10 days (pollakiuria) and headaches (headache), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy (allergy to soy, peanuts, coffee and caffeine).  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious severe pain, random rotating pain (pain), erythema, swelling in joints, hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter (joint swelling), scalp tenderness (pain of skin), confusion (confusional state), frequent urination for 10 days (pollakiuria) and headaches (headache) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.  Final diagnosis was pain, erythema, joint swelling, pain of skin, confusional state, pollakiuria and headache.  The patient was treated with Aleve and Benadryl.  The outcome was unknown for all the events.  Information on the batch number was requested.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pain of skin, Pollakiuria
Clinical narrative: severe pain, random rotating pain; erythema; swelling in joints; hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter; scalp tenderness; confusion; frequent urination for 10 days; headaches; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 82 years old male patient who experienced severe pain, random rotating pain (pain), erythema (erythema), swelling in joints, hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter (joint swelling), scalp tenderness (pain of skin), confusion (confusional state), frequent urination for 10 days (pollakiuria) and headaches (headache), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy (allergy to soy, peanuts, coffee and caffeine).  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious severe pain, random rotating pain (pain), erythema, swelling in joints, hands, fingers, ankle, foot, knee, hip, mandibular joint, masseter (joint swelling), scalp tenderness (pain of skin), confusion (confusional state), frequent urination for 10 days (pollakiuria) and headaches (headache) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.  Final diagnosis was pain, erythema, joint swelling, pain of skin, confusional state, pollakiuria and headache.  The patient was treated with Aleve and Benadryl.  The outcome was unknown for all the events.  Information on the batch number was requested.
Sex: M
Vaccine: FLUR4
Symptoms: Exposure via skin contact, No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; while administering a Flublok vaccine dripped down the patient arm, not have tightened the needle enough/No AE; Initial information received on 15-Oct-2019 and additional information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient in his 60s who while administering a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe vaccine dripped down the patient arm lot number and expiry date not reported via intramuscular route in the right arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to Wrong technique in product usage process.  It was a case of vaccine underdose and exposure via skin contact.  No adverse event 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.
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 12 years old patient came in and the pharmacist gave her Flublok, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiry date: 30-Jun-2020 via intramuscular route in unknown administration site on 12-Oct-2019.  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 inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublock with a shipping excursion was administered to a patient, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot, expiry date, route and administration site was unknown on an unknown date.  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.  The shipment was shipped on Wednesday but the package was not signed for 10:37 am today, the product was still cold to touch delivered this morning.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 3 year old child was administered Fluzone Quadrivalent .25 instead of 0.5/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 3 years old male patient who received 0.25 ml dose instead of 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.   On 17-Oct-2019, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6653BD via intramuscular route in the left thigh.  It was of actual medication error case due to vaccine underdose.  It was reported that no adverse event was observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Blood creatine phosphokinase normal, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient complained of significant pain in L arm resulting in visit to ER and urgent care hours at PCP office on same date 10/19/19. Very slight edema was noted but no erythema, no signs of infection, no fevers. Patient reported pain with any movement of arm
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Student had  Flu ( Quad), and Gardisil 9, tdap (unknown manufacturer) Men ACWY ( unknown manufacturer)  on 10/21/19 . Student came to health office with c/o  left upper arm  pain and a approximately a 2 inch swelling and redness on left deltoid.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site rash, Irritability, Pyrexia
Clinical narrative: On Sat when child woke, he was running a fever of 101.6.  Mother states there are red dots on his leg especially around the Prevnar 13 site.  Fever lasted throughout the weekend and into 10/21/2019.  Highest fever was 101.6.  Lowest was 101.4.  Tylenol did not break the fever. Mother states child very fussy and did not want to be alone in crib or in pumpkin seat. Mother took child to Pediatrician. Pediatrician stated she did not know what red dots were on Rt thigh. Mother was given instructions that if they got worse or if mother noticed any change (more red, more of them) she was to return. Pediatrician told mother she might expect at least another 2 days of fever based on immu given.  As of 1:00pm 10/22/2019, fever has broke and child not as fussy. Still has red rash/dots on Rt leg.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Site pain, muscle soreness and weakness, extreme sleepiness, chills and goosebumps, headache, mild nausea
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Piloerection, Somnolence
Clinical narrative: Site pain, muscle soreness and weakness, extreme sleepiness, chills and goosebumps, headache, mild nausea
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Pain in extremity, Skin warm
Clinical narrative: The patient states that his arm was very painful, and that it got red and was warm feeling. He also states that he was sick for about 4 days following receiving the vaccines. The patient said that he did not go to the doctor or anything for it, and that everything resolved after a few days.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Hypopnoea, Loss of consciousness, Presyncope, Seizure
Clinical narrative: Menactra and Gardasil 9 were given in left arm, patient saw the blood that appeared after needle was removed and grimaced.  I turned the fan on him and asked if he was ok, he asked for a minute before giving the Bexsero, once he stated that he was ok, and mom was in agreement, the last shot was given.  He immediately started leaning over in the chair and passed out.  Mom and I lowered him to the ground, he did not fall nor hit his head.  I called for the secretary to get a cool rag, he then started having seizure activity for approximately 45 seconds to 1 minute.   His pulse and breathing were monitored.  His breathing became very shallow and I was getting the medical equipment for resuscitation out when he came to and took a deep breath.  During this time, the ambulance was called.  He was alert and oriented x3.  I checked his BP, which was 80/40, his feet were elevated and we kept him comfortable until the ambulance arrived.   Mom wanted him evaluated at local ER.  Report given to Paramedic.  Immunization record faxed to the ER.  Mom did say that he had a seizure in April 2018 but nothing was diagnosed nor is he on any medication.  He was released from ER to home and to follow up with PCP.  ER MD made assessment of Vasovagal response post immunization.  I left a message for mom to call me back to check on patients status but she never returned my phone call.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: fever 102+, chills, headache, nausea, diarrhea, muscle/joint aches - all lasted 3-4 days second shot administered: 10/11/2019 - pre-medicated w/Tylenol - same symptoms but not as severe - fever 101, chills, muscle/joint aches, headache, no nausea
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: fever 102+, chills, headache, nausea, diarrhea, muscle/joint aches - all lasted 3-4 days second shot administered: 10/11/2019 - pre-medicated w/Tylenol - same symptoms but not as severe - fever 101, chills, muscle/joint aches, headache, no nausea
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site nodule
Clinical narrative: Donor started having headaches for 2 days starting around 2:57 am on 10/18/19.  Also started having achy painful joints that is still having.  Nodule formation to injection site.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: pt states red, painful rash on arm and into armpit of right arm where tdap was given
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in jaw
Clinical narrative: R. Jaw pain mild to moderate No treatment Resolved in 48hrs
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Swelling face
Clinical narrative: 10/19/2019 4:24am Copied from Student Health On Call Chart Note Student called provider on call, Dr, "regarding  left cheek and b/l eye swelling, awoke pt 20  mins prior to call and symptoms increasing.  Denies new foods or medications. Denies tongue and lip swelling. Denies SOB. Has allergies to tree, pllen, dogs, but no hx of allergic rxn.  Pt states has beadryl. Lives in a home with many roommates. Has friend that can go with him to ER. Advised since symptoms actively increasing to go to ER, pt agreeable. States friend will go with him.  Advised since firend able to go with him to take benadryl. Advised any onset of tongue or lip swelling, or SOB to call 911, pt agreeable.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Patient reports that within 24 hours of injection developed redness, swelling, warmth of LUE This progressed to extensive swelling, redness, warmth extending down to elbow and extending in L shoulder across anterior chest
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient reports that within 24 hours of injection developed redness, swelling, warmth of LUE This progressed to extensive swelling, redness, warmth extending down to elbow and extending in L shoulder across anterior chest
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom states that by evening of the vaccine the upper left arm started to become red and swollen. By the am the entire limb, from the shoulder to the wrist,  was swollen, red, painful and hot to the touch. Mom took him to an urgent care clinic where he received antibiotics.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Mom states that by evening of the vaccine the upper left arm started to become red and swollen. By the am the entire limb, from the shoulder to the wrist,  was swollen, red, painful and hot to the touch. Mom took him to an urgent care clinic where he received antibiotics.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test normal, Insomnia, Neuralgia, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED SEVERE PAIN IN LEFT ARM, HAS DIFFICULTY SLEEPING AT NIGHT, HAS NOT RESOLVED SINCE RECEIVING VACCINE, DESCRIBES AS NERVE TYPE PAIN DOWN ARM AND INTO WRIST