chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired Daptacel, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to case 2019SA327197 (same reporter).  This case involves 2 year old male patient who received a dose (fourth in series) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]  lot C5307AA expiry date: 23-Oct-2019 via unknown route in unknown administration site on 15-Nov-2019.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: vaccines exposed to the highest temp 50 for 24 hours, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  In this case a cold chain deviation occurred with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ300AB, Exp. Date 26-Jun-2020) on an unknown date while it was taken to a patient home.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a potential medication error case due to incorrect product storage.  It was reported that the vaccines were in the cooler and sent out of in the morning. Caller said that the highest temp 50 for 24 hours.  It was unknown whether the vaccine was administered.  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: FLU3
Symptoms: Local reaction
Clinical narrative: localized reaction; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves Elderly patient who experienced localized reaction, while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Shingrix with local reaction (6 months earlier) and TAP with no adverse event (about a month ago).  The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a 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 developed a non-serious localized reaction (local reaction) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was localized reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for localized reaction.  batch number has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Headache, Nausea, Pyrexia, Wrong product administered
Clinical narrative: general feeling of not feeling well; headache; temperature; feeling sick to the stomach; she went to get the pneumonia vaccine, but was given a second Fluzone High dose vaccine; she accidentally gave her another FluzoneHD instead of a pneumonia shot; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient who experienced general feeling of not feeling well (Feeling unwell), headache(Headache), temperature(fever), feeling sick to the stomach(Pain stomach), while she 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.   On an unknown date, the patient received second dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious general feeling of not feeling well (Feeling unwell),headache(Headache),feeling sick to the stomach (Pain stomach),temperature (fever) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It is also a case of Wrong vaccine administered, and Extra dose administered.  It was reported that given a second fluzone high dose vaccineand she accidentally gave her another fluzone hd instead of a pneumonia shot.  (Other relevant tests included no lab data).  Final diagnosis was feeling sick to the stomach, temperature, headache and general feeling of not feeling well.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events  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 is requested.
Sex: U
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: leg swelled; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Sales Representative).  This case involves a 4 years old patient who experienced leg swelled, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious leg swelled (peripheral swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant test was not reported.  Final diagnosis was leg swelled.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for leg swelled.  Information on the batch number was requested.
Sex: M
Vaccine: MNQ, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient had received 0.5ml of Menactra instead of the Mem B12 vaccination, no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received 0.5ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6522AB, expiry date: 29-Jan-2021) via unknown route in right deltoid administration site instead of MENINGOCOCCAL VACCINE B on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was a case of actual medication error due to wrong vaccine administered.  It was reported that sixteen year old, male patient had received 0.5ml of Menactra instead of the Mem B12 vaccination he was supposed to receive.  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 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.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to a 63 year old patient,no AE; Fluzone HD was administered to a 63 year old patient,no AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 63 year old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number UJ253AA, expiration date:06-MAY-2020) via intramuscular route on the right deltoid on 25-Nov-2019.   The patient' medical history and concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for unknown indication.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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: F
Vaccine: FLU3
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: achy; feeling tired; febrile; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65 years old female patient who experienced tiredness (Fatigue), febrile (Pyrexia) and achy (Pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history included underweight. The patient's past vaccinations included Influenza Vaccine. Medical treatments and family history were not provided.   On 01-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date were not reported] via intramuscular route in unknown administration site.  On unknown date, the patient developed a non-serious feeling tired (fatigue), febrile (pyrexia) and achy (pain), 2 weeks following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests included no lab data.  Final diagnosis was achy, febrile and tiredness.   It was not reported if the patient received a corrective treatment.  The patient was recovered from all events.  Information on the batch number was requested.
Age: 0.17
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 2 month 15 day old child got Quadracel/No AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two month 15 days old patient who received a vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number and expiry date were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to product administered to patient of inappropriate age.  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.  Information on the batch number was requested.
Age: 1.17
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of Ipol/No AE; Initial information received on 23-Nov-2019 and additional information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 months old female patient who received expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HAEMOPHILUS INFLUENZAE (HAEMOPHILUS INFLUENZAE) for Immunisation.  On 21-Nov-2019, the patient received third dose of 0.5 mL suspect IPV (VERO) lot N1J451M, expiry date-05-10-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: developed a redness at the injection site; a reddened hard bump at the injection site; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old female patient who had developed a redness at the injection site(Vaccination site erythema ) and a reddened hard bump at the injection site(Vaccination site mass), while she 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.    On 01-Oct-2019, the patient received a dose of 0.5ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ281AB and expiration date 16-MAY-2020 via intramuscular route in the left arm.  On 25-NOV-2019 (latency 1 month 24 days) after the initiation of suspect the patient had developed a redness at the injection site (Vaccination site erythema) and a reddened hard bump at the injection site(Vaccination site mass). It is approximately 1/4 inch in diameter.  The patient has been to her doctor, who referred her back to the pharmacy.  No laboratory result was reported.  Final diagnosis was a redness at the injection site (Vaccination site erythema) and a reddened hard bump at the injection site (Vaccination site mass).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.
Age: 69.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave an expired dose of Menatra to a 69 years old patient/No AE; accidentally gave an expired dose of Menatra to a 69 years old patient/No AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 69 year old female patient who received expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.   On 25-Nov-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6002CA, expiry date- 24-SEP-2019 via unknown route in the unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and expired vaccine used.  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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Received the Flu Shot at 7 am the morning of 11-29-2019. Went home after getting off of working a night shift and went to bed. Woke up 11-29-2019 around 4:30 pm and noticed some itching to both legs and arms around 6:00 pm. Applied some hydrocortisone 1 % she  had at home to both legs and arms for the itching. Made an appointment to be seen on 12/3/2019 by the CRNP.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: She was itching and had red "hives".  Was sent to ER from Employee Health Services.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Patient woke up the day after Shingrix administration with a headache, muscle aches, and fever/chills.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; on11-NOV-2019, a dose of PROQUAD which expired on 21-OCT-2019 was inadvertently administered to the patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-NOV-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (exact dose and route of administration were not reported) (lot # R011802, expiry date 21-OCT-2019) for prophylaxis.  No adverse effects were reported. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Feels it may be decreasing the incidence of cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of unexpected therapeutic drug effect in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient asked does the shingrix vaccine have any affect on cold sores incident or severity. The reporter stated that the patient felt that it may be decreasing the incidence of her cold sores. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: unspecified allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (gentamycin allergy).   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were received as follows: The case was reporter by patient's mother. The age at vaccination was not reported. The reporter stated that after vaccination the patient experienced unspecified allergic reaction. No other details were available at time of reporting. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Rash
Clinical narrative: Pain at the injection site; Rash; Fever; Nausea; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th February 2021) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, rash, fever and nausea. On an unknown date, the outcome of the injection site pain, rash, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, rash, fever and nausea to be related to Shingrix.  Additional case details were reported as follows: The health care professional reported pain at the injection site, rash fever, nausea and said the symptoms last over 7 days and wanted to know if the patient should receive the second dose. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: Mother reports the start of a rash at the site of injection on the right arm where varicella vaccine administered on 11/18/19 that got worse and spread. Also reported visible lymph nodes in neck. Rash has gotten better as of today 12/3/19. Lymph nodes still visible per mother.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Headache, Injection site pain, Insomnia, Neck pain
Clinical narrative: I have had chronic, progressive pain in my left shoulder after receiving the influenza vaccination. The injection site felt high on my shoulder the day I received it and I have had chronic pain from the site radiating down my arm, as well as to my neck and upper back ever since. I also experience sharp pains during left arm abduction and front raise movements as well as headaches. I work at a hospital and the nurse I work with got the vaccine as well. We both felt that the injection was far too high. The pain and movement restrictions are progressively increasing as well as the headaches and it has greatly inhibited my sleeping.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: I have had chronic, progressive pain in my left shoulder after receiving the influenza vaccination. The injection site felt high on my shoulder the day I received it and I have had chronic pain from the site radiating down my arm, as well as to my neck and upper back ever since. I also experience sharp pains during left arm abduction and front raise movements as well as headaches. I work at a hospital and the nurse I work with got the vaccine as well. We both felt that the injection was far too high. The pain and movement restrictions are progressively increasing as well as the headaches and it has greatly inhibited my sleeping.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: patient developed hives and itchiness around her neck and chest roughly 15 minutes post-vaccination. Pt was given 50mg of liquid diphenhydramine and water. pt refused ambulance, went home, reported the hives had cleared, and said she was going to take a nap and call back when she woke up. pt called back between 4 and 5pm same day and said the hives were still gone and she was feeling fine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: I received a seasonal influenza vaccine (in the left arm) at the same time and location as #17; I do not know the brand or dosage of the influenza vaccine; later that night, I felt as if I had influenza; I felt hot, but at the same time, I was shivering almost uncontrollably for about one hour while trying to sleep; on the subsequent day (11-27), I had a headache, fatigue and joint pain until late afternoon; I am unable to say with certainty that it was solely due to the influenza vaccine or the shingrix vaccine or a combination of the two; my right arm (location of the shingrix vaccine) was very sore for several days, with a light red rash about a 1" radius around the site of the injection
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: I received a seasonal influenza vaccine (in the left arm) at the same time and location as #17; I do not know the brand or dosage of the influenza vaccine; later that night, I felt as if I had influenza; I felt hot, but at the same time, I was shivering almost uncontrollably for about one hour while trying to sleep; on the subsequent day (11-27), I had a headache, fatigue and joint pain until late afternoon; I am unable to say with certainty that it was solely due to the influenza vaccine or the shingrix vaccine or a combination of the two; my right arm (location of the shingrix vaccine) was very sore for several days, with a light red rash about a 1" radius around the site of the injection
Age: 1.83
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt received vaccine, upon waiting for a post immunization screening, pt presented with hives, redness, and swelling at MMR and Varicella injection sites. PCP notified, and provider ordered benadryl PO. After waiting an additional 5 min per provider, redness and swelling had decreased.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on face, neck, and arms for 1 week. Given steroid shot.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: After patient received HPV injection  became diaphoretic and nauseous/vomiting.  After about 2-3 minutes was examined by health care provider  and VS normal .  Patient was observed for 10-15 minutes  and stated that he was feeling better.  Patient was then walked back to class, school nurses notified of the event  and parent was called about this.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Impaired work ability, Migraine, Myalgia
Clinical narrative: Severe Migraine, Vomiting, Muscle Pain, Nausea, Fatigue that lead to a chronic Cough and Cold which inhibits ability to work comfortably and inability to sleep  properly for weeks.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Nasopharyngitis, Nausea, Poor quality sleep, Vomiting
Clinical narrative: Severe Migraine, Vomiting, Muscle Pain, Nausea, Fatigue that lead to a chronic Cough and Cold which inhibits ability to work comfortably and inability to sleep  properly for weeks.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Wrong dosage was given. Patient over 65 should have recieved Fluzone High Dosage for over 65 years old.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Feeling cold, Hypoaesthesia, Pyrexia
Clinical narrative: Fever, Chills, joint pain (shoulders, elbows, wrists, hips, knees, and ankles), numbness right cheek
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: I had the usual stiffness for a day and nothing for about one week.  Then I noticed it hurts to raise my arm over my head.  Anytime I move my arm, it hurts.  I've tried stretching it with Yoga but to no avail.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: 15 minutes after leaving office, parent noticed face bright red,. Parent advised to monitor child. 6 hours later developed raised rash all over both legs. Provider advised  Benadryl 6.25 mg q6 hours and Tylenol 3/4 tsp q4-6 hours and if gets worse to ER. The next morning parent called an advised as soon as Benadryl wears off, the rash comes back. parent states hives on face, eye and on his back also now.  Pt coming in to see provider this afternoon.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: 1 hour after vaccination, the patient started to experience nausea, which was followed with emesis and loose stool. The patient reported to clinic on 3 Dec 2019 with persistent symptoms of nausea, however with decreased emesis and loose stool. Despite symptoms, patient maintained normal vital signs. He also reports that vaccination in 2018 (Seqirus YF39708, 11 Oct 2018) he had the same symptoms that resulted in an emergency room visit for rehydration. Today, he was treated with zofran, counseled regarding hydration and diet, and sent home for 48 hours.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Fatigue, Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: Unusual Fatigue (periods of 14-15 hours sleep), Low grade fever on and off,  appetite loss, almost two weeks after a raised injection site and red rashy arm
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse events; patient was administered a GARDASIL 9 vaccine instead of an unspecified PNEUMONIA vaccine; an 83 year old patient was administered a GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist and refers to a 83 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis, instead of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "unspecified pneumonia vaccine"). No adverse events were reported.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient then missed subsequent doses in the HPV vaccine series.; Miscellaneous was chosen as the product type as it could not be determined if first dose in the vaccination series was GARDASIL quadrivalent or GARDASIL 9.; This spontaneous report was received from a pharmacist referring to a 16-year-old male patient. The patient's concurrent condition, medical history, drug allergies/ reaction and concomitant medications were not reported. On an unknown date in 2016 (reported as about three years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (strength, formulation, dose/frequency, route, lot# and expiry date were unknown) for prophylaxis (product origin unknown). On an unknown date, the patient missed subsequent doses in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) vaccine series (product dose omission). The outcome of product dose omission and product origin unknown was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Rash
Clinical narrative: rash (vertical) on each side and across my back; had a red wide band of red skin on; felt unwell for days but nothing severe; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 18th September 2019, the patient experienced rash and erythema. On an unknown date, the outcome of the rash, feeling unwell and erythema were unknown.   It was unknown if the reporter considered the rash, feeling unwell and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix, and she felt unwell for days but nothing severe. 24 hours later in the evening, she undressed and noticed a rash (vertical) on each side and across my back also. She had a red wide band of red skin on the top of her abdomen under her bra area. She had consulted with pharmacist and physician but they were unaware about how to advise her. The reporter consented to follow up.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart attack (had heart attack at end of september).   On 25th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced heartbeats increased. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fast heartbeat. The patient had heart attack so the reporter reported to carefull with unusual changes. The patient reported that had not checked blood pressure yet.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: shoulder soreness; diminished range of motion; injection site pain; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number BP959, expiry date 30th June 2020) for prophylaxis.   On 14th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 14th October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 14th November 2019, the patient experienced shoulder soreness and joint range of motion decreased. On an unknown date, the outcome of the injection site pain, shoulder soreness and joint range of motion decreased were unknown.   It was unknown if the reporter considered the injection site pain, shoulder soreness and joint range of motion decreased to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 season on left arm. The patient experienced pain at the injection site the same day.  Over an unspecified period of time, the patient began to experience a sore shoulder and a diminished range of motion described as difficulty moving the arm and putting on a shirt. The reporter consented to follow up.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 9 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced chills about 9 to 14 days after receiving the vaccine. The patient again reported second episode of chills around 15th November 2019 which lasted for 2 to 3 days. No additional information was provided The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: sore arm; injection site rash; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and injection site rash. On an unknown date, the outcome of the pain in arm and injection site rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient received dose of Shingrix and later developed a sore arm and an injection site rash that lasted a week. The reporter consented to follow up. The reporter declined to provide any further information for this adverse event.
Age: 89.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in the arm; pain radiates down her arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 18th September 2019, the patient received Shingrix and FLUAD. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and radiating pain. On an unknown date, the outcome of the pain in arm and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and radiating pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient received Shingrix and Fluad in the same arm and developed pain in arm that radiated down her arm which she was still experiencing. All patient identifiers were provided. No data available for batch number or expiration date. It was unknown if the reporter considered the pain in arm and radiating pain to be related to FLUAD. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix (dose number unknown) and shortly after developed a cold sore (timing of cold sore not known). The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Flushing
Clinical narrative: Flushing on cheeks and lower abdomen; Burning sensation on cheeks and lower abdomen; Burning sensation on cheeks and lower abdomen; This case was reported by a pharmacist via call center representative and described the occurrence of facial flushing in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date unknown) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced facial flushing, burning sensation in face and burning sensation in abdomen. On an unknown date, the outcome of the facial flushing, burning sensation in face and burning sensation in abdomen were unknown.   It was unknown if the reporter considered the facial flushing, burning sensation in face and burning sensation in abdomen to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was complaing of a flushing, burning sensation on cheeks and lower abdomen. The patient thought it may be associated with the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: extreme pain when moving the arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) (batch number 2CPQB ?, the reported lot number doesn't match any GSK lot number, expiry date 12th April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 77 or 78 years.  Post vaccination with Shingrix the patient felt extreme pain while moving the arm of the injection. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Appendicitis perforated, Computerised tomogram abdomen abnormal
Clinical narrative: A couple of days following patient's vaccination of DTaP, he was complaining of nausea and stomach pain. He rested for a couple of days, but then on Monday the 28th, he began to throw up bright green fluid. We thought he might have a flu, so we waited 24 hours to see if the vomiting would stop. On Tuesday the 29th, he threw up once in the morning. He continued to rest that day, but he refused to drink or eat anything. On Wednesday the 30th, he was very lethargic and would only drink a few sips at a time. I noticed that he was showing signs of dehydration, so we tried to get him to drink more fluids, but he would resist. On Thursday the 31st, I took him into Urgent Care, as his symptoms weren't improving and he was indicating a worsening pain in his stomach. They sent us to the ER, where they took a CT scan, which showed that his appendix was inflamed. From the time we left the CT and up to surgery, his appendix had ruptured. Due to the contamination in his system, he stayed in the hospital for a week.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Dehydration, Diet refusal, Discoloured vomit, Lethargy, Nausea
Clinical narrative: A couple of days following patient's vaccination of DTaP, he was complaining of nausea and stomach pain. He rested for a couple of days, but then on Monday the 28th, he began to throw up bright green fluid. We thought he might have a flu, so we waited 24 hours to see if the vomiting would stop. On Tuesday the 29th, he threw up once in the morning. He continued to rest that day, but he refused to drink or eat anything. On Wednesday the 30th, he was very lethargic and would only drink a few sips at a time. I noticed that he was showing signs of dehydration, so we tried to get him to drink more fluids, but he would resist. On Thursday the 31st, I took him into Urgent Care, as his symptoms weren't improving and he was indicating a worsening pain in his stomach. They sent us to the ER, where they took a CT scan, which showed that his appendix was inflamed. From the time we left the CT and up to surgery, his appendix had ruptured. Due to the contamination in his system, he stayed in the hospital for a week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Urticaria, Vulvovaginal erythema
Clinical narrative: Patient reported large red circle around injection site along with itching and redness--also reactivated prior shingles in vaginal area with large red welts and circle of redness around vaginal area
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling jittery, Migraine, Pain in extremity, Tremor
Clinical narrative: Patient came to the pharmacy and said she feels shaky, jittery, dizzy, has bad headache migraine-like happened 30 minutes after vaccine and pt is still feeling it now. Her arm hurts but not too bad. I asked pt to stay for 10-15 minutes after vaccine to walk around the store to make sure everything is ok and to check back with us, pt did not check back with us yesterday. Recommended pt to go to urgent care and will check on her or she will check with us if there is any issues. Patient will talk to her manager today to see if she can get off work and go to urgent care.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Confusional state, Fatigue, Myalgia
Clinical narrative: Prolonged fatigue, muscles aches, confusion, weakness for 4-5 days
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Polymyalgia rheumatica
Clinical narrative: Diagnosed with polymyalgia rheumatica; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of polymyalgia rheumatica in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and myalgia. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica and myalgia were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and myalgia to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left arm. The patient was diagnosed with polymyalgia rheumatica. Additional information was not provided. The reporter consented to follow up. This case has been linked with case US2019215233, reported by same reporter.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: -extra dose of KINRIX given - no adverse symptoms were noted.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: None stated.