chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Aggression, Blindness unilateral, Urinary retention
Clinical narrative: Could not Pee; Patient launched into a stream of explectives/ as verbally aggressive and used multiple expletives during the conversation; Patient received an unspecified HPV vaccine; Lost vision in one eye; This spontaneous report was received from a male patient reporting on himself (age unknown). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient  was vaccinated with an unspeified HPV vaccine (manufacturer unknown) (also reported as an unspecified "vaccine shot"), for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, the patient was not able to urinate (reported as "cannot pee", so he went to the hospital for medical attention, the patient mentioned that "5 days" but it was not clear if refers to  5 days hospitalized or that he received the vaccination 5 days ago.  The patien also mentioned that after vaccinatin with an uspecifed HPV vaccine, he lost the vision in one eye and as a result turned into a "Pirate".   It was also noted that during the call the patient was verbally aggresive and used multiple expletives during the conversation (Verbal aggression )   At the time of the report the patient was not recoverd from lost the vision in one eye.  The patient's outcome of "cannot pee" and Verbal aggression was unknown.  The causal relationship between the aforementioned events and  unspecified HPV vaccine was not reported.  Upon internal review, lost the vision in one eye was considered to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Blepharitis, Herpes zoster, Pneumonia, Rash, Visual impairment
Clinical narrative: pneumonia; vitreous floaters; blepharitis; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-APR-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a rash and visual impairment and was diagnosed with shingles, vitreous floaters and blepharitis. In the weeks following these diagnoses, patient additionally suffered and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. Causality assessment between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: pneumonia; vitreous floaters; blepharitis; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-APR-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a rash and visual impairment and was diagnosed with shingles, vitreous floaters and blepharitis. In the weeks following these diagnoses, patient additionally suffered and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. Causality assessment between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, pneumonia was considered to be medically significant.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Noo additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; This spontaneous report was received from a vaccine coordinator and refers to a 4 month old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-MAR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1658255, expiration date 07-FEB-2021 (dose and frequency were not provided) for prophylaxis. No additional adverse effects reported. Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion below 2 Celsius degrees (C): 0.8 C for 5 hours and 9 minutes on 02-MAR-2020; 0.9 C for 11 hours on 04-MAR-2020 and -1.3 C for 9 hours and 29 minutes on 05-MAR-2020. There was previous temperature excursions reported. The administered doses of the suspect vaccine experienced the temperature excursion above 9 C: 9.3 C for 3 hours and 33 minutes on 25-FEB-2020 and below 2 C: 0.8 C for 11 hours 39 minutes on 03-MAR-2020. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; now both of them have shingles.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were received as follows:  This case is reported via chat. The reporter clients parent's got the shingles caccine and at the time of reporting, both of them have shingles.  The reporter asked, should I worry about client getting it from them. The male patint was mentally handicapped and has seizure disorder. The reporter don't know, how long ago the patient got the vaccine. The reporter was not a group home provider and do not hold a medical license of any kind. The reporter wasnted to know if need to worry about him having been in contact with them. This case was linked with US2020AMR044963, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; now both of them have shingles.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were received as follows:  This case is reported via chat. The reporter clients parent's got the shingles caccine and at the time of reporting, both of them have shingles.  The reporter asked, should I worry about client getting it from them. The male patint was mentally handicapped and has seizure disorder. The reporter don't know, how long ago the patient got the vaccine. The reporter was not a group home provider and do not hold a medical license of any kind. The reporter wasnted to know if need to worry about him having been in contact with them. This case was linked with US2020AMR044954, reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Ear infection, Ear pain, Facial paralysis, Headache
Clinical narrative: had hearing loss; Facial paralysis; his right ear was inflamed; sores in the ear/ ear pain/ ear sore; Ramsey Hunt Syndrome; Headache; This case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 31st March 2022) for prophylaxis.   On 22nd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd February 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced headache. On 23rd February 2020, the patient experienced ramsay-hunt syndrome (serious criteria GSK medically significant) and ear pain. On 26th February 2020, the patient experienced otitis. On 27th February 2020, the patient experienced facial paralysis (serious criteria GSK medically significant). On 2nd March 2020, the patient experienced hearing loss unilateral (serious criteria GSK medically significant). The patient was treated with cefalexin (Keflex), valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the ramsay-hunt syndrome and facial paralysis were not recovered/not resolved and the outcome of the hearing loss unilateral, headache, otitis and ear pain were recovered/resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, facial paralysis, hearing loss unilateral, headache, otitis and ear pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient's wife. The patient received Shingrix and had headache on the same day.  On 23rd February 2020S, he had ear pain and that on 26th February 2020, his right ear was inflamed.  On the day after that (27th February) he developed sores in the ear and facial paralysis.  On 2nd March 2020, he had full blown Ramsay Hunt syndrome.  The patient was initially treated with Keflex, because the doctor thought he had a bacterial infection, but that the symptoms progressed.  He was then given Valtrex, 1 gram in every 8 hours and was also placed on Prednisone for several days. The patient also had hearing loss of the right ear.  The patient's condition had improved but that he still had residual facial paralysis. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Skin ulcer
Clinical narrative: had hearing loss; Facial paralysis; his right ear was inflamed; sores in the ear/ ear pain/ ear sore; Ramsey Hunt Syndrome; Headache; This case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 31st March 2022) for prophylaxis.   On 22nd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd February 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced headache. On 23rd February 2020, the patient experienced ramsay-hunt syndrome (serious criteria GSK medically significant) and ear pain. On 26th February 2020, the patient experienced otitis. On 27th February 2020, the patient experienced facial paralysis (serious criteria GSK medically significant). On 2nd March 2020, the patient experienced hearing loss unilateral (serious criteria GSK medically significant). The patient was treated with cefalexin (Keflex), valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the ramsay-hunt syndrome and facial paralysis were not recovered/not resolved and the outcome of the hearing loss unilateral, headache, otitis and ear pain were recovered/resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, facial paralysis, hearing loss unilateral, headache, otitis and ear pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient's wife. The patient received Shingrix and had headache on the same day.  On 23rd February 2020S, he had ear pain and that on 26th February 2020, his right ear was inflamed.  On the day after that (27th February) he developed sores in the ear and facial paralysis.  On 2nd March 2020, he had full blown Ramsay Hunt syndrome.  The patient was initially treated with Keflex, because the doctor thought he had a bacterial infection, but that the symptoms progressed.  He was then given Valtrex, 1 gram in every 8 hours and was also placed on Prednisone for several days. The patient also had hearing loss of the right ear.  The patient's condition had improved but that he still had residual facial paralysis. The reporter consented to follow up.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Influenza, Influenza like illness, Pain
Clinical narrative: Symptoms indicative of flu; Flu like symptoms; This is a spontaneous case from, initially received from other non-health professional via agency (reference number: SEQW20-00157) on 15-Mar-2020 and additional document received on 16-Mar-2020 (being processed together), concerning a 30-year-old, female patient.  The patient's medical history was not reported.  The patient's concomitant medications were not provided.  On an unspecified date in Oct-2019, the patient was administered unspecified INN flu vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for influenza prophylaxis.  On 14-Mar-2020, in the late evening, an unknown amount of time after vaccination, the patient developed flu like symptoms which had a rapid onset and included fatigue, body aches, chills and fever. Given the current national emergency, the patient was advised by a health care professional to not go and get tested for coronavirus as the symptoms and onset do not match but are more indicative of flu.  At the time of the report, the outcome of all the events was unknown.  The reporter assessed the case as non-serious and did not provide causality assessment to unspecified flu vaccine.  Company comment: The patient developed flu like symptoms approximately five months after receiving unspecified INN flu vaccine. The vaccine was administered on an unspecified date in Oct-2019. A health care professional stated that the symptoms are indicative for flu. More information regarding diagnostic and laboratory findings is needed. With information available, causality is assessed as related.; Sender's Comments: The patient developed flu like symptoms approximately five months after receiving unspecified INN flu vaccine. The vaccine was administered on an unspecified date in Oct-2019. A health care professional stated that the symptoms are indicative for flu. More information regarding diagnostic and laboratory findings is needed. With information available, causality is assessed as related.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Symptoms indicative of flu; Flu like symptoms; This is a spontaneous case from, initially received from other non-health professional via agency (reference number: SEQW20-00157) on 15-Mar-2020 and additional document received on 16-Mar-2020 (being processed together), concerning a 30-year-old, female patient.  The patient's medical history was not reported.  The patient's concomitant medications were not provided.  On an unspecified date in Oct-2019, the patient was administered unspecified INN flu vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for influenza prophylaxis.  On 14-Mar-2020, in the late evening, an unknown amount of time after vaccination, the patient developed flu like symptoms which had a rapid onset and included fatigue, body aches, chills and fever. Given the current national emergency, the patient was advised by a health care professional to not go and get tested for coronavirus as the symptoms and onset do not match but are more indicative of flu.  At the time of the report, the outcome of all the events was unknown.  The reporter assessed the case as non-serious and did not provide causality assessment to unspecified flu vaccine.  Company comment: The patient developed flu like symptoms approximately five months after receiving unspecified INN flu vaccine. The vaccine was administered on an unspecified date in Oct-2019. A health care professional stated that the symptoms are indicative for flu. More information regarding diagnostic and laboratory findings is needed. With information available, causality is assessed as related.; Sender's Comments: The patient developed flu like symptoms approximately five months after receiving unspecified INN flu vaccine. The vaccine was administered on an unspecified date in Oct-2019. A health care professional stated that the symptoms are indicative for flu. More information regarding diagnostic and laboratory findings is needed. With information available, causality is assessed as related.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Hallucinations, mixed, Intentional self-injury
Clinical narrative: parent reports that patient started having symptoms on 1/27/20 of severe anxiety, auditory and visual hallucinations. Self harm. multiple episodes requiring in patient psychiatric care for 1 week. These symptoms having been occurring over the last 6 weeks.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Severe body aches, nausea, fatigue
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Body temperature increased, Erythema, Headache, Hyperhidrosis, Influenza
Clinical narrative: Purple Palms - 2 pm Fri. - Ventolin MDI - SOB 2 puffs x 1 @ 3 pm Sat. a.m. - 8 AM - Nausea, - V-8 T - 101 - p.m. - Flu Symptoms, Advil 200 mg x 2, sweating, H/A, Erythema - Diffuse - (L) Side Neck Sun. - T - 100 Mon. - T - 99.2 Hx - Varicella - Internally Presented with this Reaction 24 hrs. post-vaccination Erythema + Edema at Injection site Shingrix arm 65 mm W x 30 mm L PCV 13 arm 60 mm W x 40 mmL Fever - 101 degrees F oral, Diffuse erythema on (L) side of neck down shoulders + (L) UA. @2 hrs. post vaccination - Palms of both hands - purple. Took 2 puffs MDI - Sx Resolved.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nausea, Skin discolouration
Clinical narrative: Purple Palms - 2 pm Fri. - Ventolin MDI - SOB 2 puffs x 1 @ 3 pm Sat. a.m. - 8 AM - Nausea, - V-8 T - 101 - p.m. - Flu Symptoms, Advil 200 mg x 2, sweating, H/A, Erythema - Diffuse - (L) Side Neck Sun. - T - 100 Mon. - T - 99.2 Hx - Varicella - Internally Presented with this Reaction 24 hrs. post-vaccination Erythema + Edema at Injection site Shingrix arm 65 mm W x 30 mm L PCV 13 arm 60 mm W x 40 mmL Fever - 101 degrees F oral, Diffuse erythema on (L) side of neck down shoulders + (L) UA. @2 hrs. post vaccination - Palms of both hands - purple. Took 2 puffs MDI - Sx Resolved.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema, hives on chest and legs. ER administered epinephrine and prednisone
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chills, Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Fever of 106.8 on 3/17/2020 and not eating or drinking. Temp in the office 103.1. Patient had chills and one loose stool (not diarrhea per mom). Reassuring exam per provider, offered cath but the parent declined. Sent home with instructions to continue to monitor, Tylenol or Motrin as directed. Call for appointment the following day if still with fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine administered in left deltoid. Patient reported arm pain, swelling, bruise. Bruising cleared after 3 weeks, arm pain continues intermittently, dull ache, then sharp "bee sting"
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Culture negative, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Imms given 3-4 and 3-6 patient developed a very red swollen upper arm with blistering. Arm was twice its size and red from elbow to shoulder. She was taken to Urgent Care, dx cellulitis, started on Keflex. Follow up with PCP 3-7-20. Redness and swelling improved. Blister unroofed and cultured: no Growth!
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Infectious mononucleosis
Clinical narrative: mononucleosis; This spontaneous report was received from a nurse practitioner and refers to a 12-year-old male patient. He had no pertinent medical history, no drug reactions or allergies and no concomitant therapy. On 27-NOV-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot number, expiration date and dose were not reported) for the prevention of human papilloma virus (HPV). On 26-MAR-2018, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot number, expiration date and dose were not reported) for the prevention of HPV. On an unknown date in October 2019, the patient was diagnosed with mononucleosis. The patient sought medical attention and had an office visit, however, no treatment was given to the patient for the event. Also no lab diagnostics or studies were performed. The outcome of the event was reported as recovered on an unknown date. The relatedness between the event and suspect therapy was not provided.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reports; patient was administered improperly stored ROTATEQ; This spontaneous report as received from a vaccine coordinator refers to a 8-week-old female patient. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.  On 25-FEB-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1658255, expiration date 07-FEB-2021 (route of administration, dose and frequency not reported) for prophylaxis.      Digital data logger was involved. The vaccine was stored at the temperature that was reported as below 2 degrees of C: on 02-MAR-2020 0.8 degrees of C for 5 hours and 9 minutes; 04-MAR-2020 0.9 degrees of C for 11 hours and 05-MAR-2020 -1.3 degrees of C for 9 hours and 29 minutes. The previous temperature excursion happened on 25-FEB-2020 and the temperature was reported as above 9 degrees of C (9.3 degrees of C) for 3 hours 33 minutes and on 03-MAR-2020 below 2 degrees of C (0.8 degrees of C) for 11 hours 39 minutes.  No adverse effect reported.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of ActHIB and Daptacel were administered to two month old patient, No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who was administered with an expired dose of HAEMOPHILUS TYPE B (HIB) (Act-HIB) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (DAPTACEL).  Medical history, medical treatment, vaccination and family history were not provided.  On 10-Mar-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (DAPTACEL) (lot C5367A and expiration date 30 -Jan-2020) via an intramuscular route in the right leg and also 0.5 ml dose of suspect HAEMOPHILUS TYPE B (HIB) vaccine (Act-HIB) (lot UI937AAA and expiration date 05-Nov-2019) via an intramuscular route in the left leg for prophylactic vaccination.  It was an 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 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: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired Daptacel vaccine / no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 months old female patient who was vaccinated expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number C5367AA (Expiry date 30-Jan-2020) via unknown route in the left thigh on 11-Mar-2020 for Prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB), HEPATITIS A VACCINE (HEPATITIS A) and INFLUENZA VACCINE (INFLUENZA).  It was an actual medication error case due to expired vaccine used.  At a time of reporting 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 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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a four different patients received an expired dose of Daptacel vaccine which was expired on 30Jan2020/No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from the  other health care professional.  This case involves four patient (gender unknown) who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] which was expired on 30-Jan-2020 and was administered to these patients on 20Feb2020, 24Feb2020, 25Feb2020, and 04Mar2020 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  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 report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder pain; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult patient (unknown demographic) who experienced shoulder pain (musculoskeletal pain), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious shoulder pain (musculoskeletal pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests were not reported.  Final diagnosis was musculoskeletal pain.   It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome of the event was not reported.  Information on the batch number was requested.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 4 month old was given Fluzone Quadrivalent/no AE; Initial information was received on 10-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves a four month old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] for prophylactic vaccination (lot UJ305AA, expiry date-30-Jun-2020) via intramuscular route in the right thigh for prophylactic vaccination on 10-Mar-2020 (PT: Product administered to patient of inappropriate age)..  Medical history, past medical treatments, vaccinations and family history were not provided.  Patient also received Rotateq and Pentacel on 10-Mar-2020 as concomitant therapies (No dosing details were provided).   It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the physician was aware but didn't order the medications.  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: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsey
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone, Bradycardia, Electrocardiogram, Metabolic function test, Ventricular extrasystoles
Clinical narrative: patient developed 2 days of bradycardia to low 40s with occasional PVCs.  No other cause found.  apparently this is a potential known  side effect to vaccine
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Pt felt nauseated after administration. After resting 15 minutes, drinking some water, and eating a piece of candy, adverse event subsided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Around 7pm, head started aching and aches went down to shoulders and neck.  Patient had chills overnight and ached all over.  In the morning patient felt: nausea, stomach sore, head ached, very tired so went back to bed. In the morning patient started taking Tylenol and then Ibuprofen.   Patient ate some food to take the Tylenol but was not hungry.  Patient laid down around again later on and started to feel better by 7pm.  Today patient feels better but has diarrhea; headache and other symptoms resolved.  Patient ate a good dinner but did not feel like eating most of the day. Patient did not call doctor at any point.   Arm was aching after vaccine and then it got worse; arm is just tender now. Vaccine area did not did not get red just tender
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Around 7pm, head started aching and aches went down to shoulders and neck.  Patient had chills overnight and ached all over.  In the morning patient felt: nausea, stomach sore, head ached, very tired so went back to bed. In the morning patient started taking Tylenol and then Ibuprofen.   Patient ate some food to take the Tylenol but was not hungry.  Patient laid down around again later on and started to feel better by 7pm.  Today patient feels better but has diarrhea; headache and other symptoms resolved.  Patient ate a good dinner but did not feel like eating most of the day. Patient did not call doctor at any point.   Arm was aching after vaccine and then it got worse; arm is just tender now. Vaccine area did not did not get red just tender
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: Around 7pm, head started aching and aches went down to shoulders and neck.  Patient had chills overnight and ached all over.  In the morning patient felt: nausea, stomach sore, head ached, very tired so went back to bed. In the morning patient started taking Tylenol and then Ibuprofen.   Patient ate some food to take the Tylenol but was not hungry.  Patient laid down around again later on and started to feel better by 7pm.  Today patient feels better but has diarrhea; headache and other symptoms resolved.  Patient ate a good dinner but did not feel like eating most of the day. Patient did not call doctor at any point.   Arm was aching after vaccine and then it got worse; arm is just tender now. Vaccine area did not did not get red just tender
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Muscle spasms, Neuralgia, Pain in extremity
Clinical narrative: Lower back started having spasms a week after vaccination.  Chiropractor and Dr. felt that this could have been from the heavy metals in the vaccination settling in my lower back.  I completed 2 rounds of Acupuncture and the symptoms subsided.  Approximately 4 weeks ago, around Feb 23, 2020, my lower back had severe muscle spasms on my right lower lumbar region.  I was able to get them to subside and went to the chiropractor that week.  After 2 more weeks of lower back pain, muscle spasms.and pain radiating down my sciatic nerve into my leg and ankle with my hamstring and calf muscle spasming, I went to my acupuncture doctor and she stated that these spasms could be from the vaccination and suggested that I file a report just in case.  I had a muscle spasm on my left side lumbar region on 3/18/2020 and immediately the pain started radiating down my left leg.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt has the shot on 3-2-20. Called and spoke to Rph on 3-18-20 about her arm being sore for a week and hurt when she tries to raise her hand up. Rph advised pt to seek medical doctor for advice.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Rash pruritic, Vision blurred
Clinical narrative: About one week after receiving my injection, I started feeling a low level headache on the right side of my head and above my right eye. Gradually over time, a low level rash/small bumps started appearing above my right eye brow, becoming a little scratchy. My vision in my right eye started becoming less focused/blurry. I mentioned these symptoms to Dr., my primary care doctor, at the Medical Clinic. Dr. diagnosed this as Shingles, and referred me to the Eye Center, where I was seen by Dr., who also diagnosed this as Shingles. Dr prescribed 1000 mg of Valacyclovier, twice a day, perhaps for life. The headache and rash has resided, however my vision in my right eye remains less focused/blurry.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: About one week after receiving my injection, I started feeling a low level headache on the right side of my head and above my right eye. Gradually over time, a low level rash/small bumps started appearing above my right eye brow, becoming a little scratchy. My vision in my right eye started becoming less focused/blurry. I mentioned these symptoms to Dr., my primary care doctor, at the Medical Clinic. Dr. diagnosed this as Shingles, and referred me to the Eye Center, where I was seen by Dr., who also diagnosed this as Shingles. Dr prescribed 1000 mg of Valacyclovier, twice a day, perhaps for life. The headache and rash has resided, however my vision in my right eye remains less focused/blurry.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: patient sent letter to pharmacy that she developed severe pain and swelling after getting vaccines and said she developed cellulitis on november 29th, which was days after immunization. letter states that this is negligent because patient got both shots on same day and in same arm, which are normal procedures here
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Abdominal distension, Crying, Injection site pain
Clinical narrative: Crying for over an hour the evening after the vaccine, along with apparent leg pain and mild swelling at the site of the DTaP/IPV/Hib vaccine
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: PATIENT REPORTED THAT THE MORNING AFTER VACCINATION, A BRUISE/SWOLLEN AREA FORMED. THE INJECTION SITE WAS SWOLLEN, RED, AND WARM TO THE TOUCH. THE BRUISED SITE GREW IN DIAMETER. THE PATIENT REPORTED THE EVENT ON 3/14/20, AND WAS ADVISED TO WAIT 24 HOURS BEFORE SHOWING US THE BRUISE AGAIN. THE PATIENT PRESENTED AGAIN ON 3/15/20 AND WAS ADVISED TO MONITOR FOR PROGRESSION, BUT THE PATIENT SAID IT WAS BEGINNING TO GO DOWN AND RECEDE. THE PATIENT WAS CALLED TODAY, 3/18/20, BUT REPORTED THE BRUISED AREA IS STILL 2" ACROSS AND SEEMS TO BE CHANGING COLOR. PATIENT WAS ADVISED TO CONTINUE TO SELF MONITOR, BUT TO SEEK MEDICAL ATTENTION IN THE EVENT THAT THE SWELLING/BRUISING SPREADS. THE PATIENT VERBALIZED UNDERSTANDING.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hallucination, Hyperhidrosis, Nausea, Somnolence
Clinical narrative: I became nauseous early on prior to dinner. When I went to be around 10 that evening, I fell asleep early on and then woke up with shivers and then sweats. I felt like I was hallucinating all night. When I woke up the next morning I spent the entire day on the couch going in and out of sleep. It was awful
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient had a rash around her neck that appeared 1 day after administration and lasted for 2 days. She took Benadryl to relieve the itchiness/ redness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine around 5:30 pm, by 2:30 am I awakened with aches all over my body.  I went back to sleep and when I awakened i had a low grade fever 99+ and was very fatigued and had a headache and slight pains in my head.  I slept all day except to eat and go to the rest room.  Same reactions the next 2 days but second day the fever went as high as 101.2 for a period of time, 3rd day the fever was low grade again.  Arm was red and raised below injection site and about half of my upper arm.  Had sinus pressure and mild headache and swollen lymph nodes (glands) in throat for the next 2 weeks.  Did not report to doctor as gradually improved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Received vaccine around 5:30 pm, by 2:30 am I awakened with aches all over my body.  I went back to sleep and when I awakened i had a low grade fever 99+ and was very fatigued and had a headache and slight pains in my head.  I slept all day except to eat and go to the rest room.  Same reactions the next 2 days but second day the fever went as high as 101.2 for a period of time, 3rd day the fever was low grade again.  Arm was red and raised below injection site and about half of my upper arm.  Had sinus pressure and mild headache and swollen lymph nodes (glands) in throat for the next 2 weeks.  Did not report to doctor as gradually improved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: My left arm has been painful and very weak since injection. It doesn?t seem to be improving with time. I know I need the 2nd shot in 6 months but not looking forward to it.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Peripheral swelling, Skin tightness
Clinical narrative: Swelling of arm, redness, tightness and muscle pain.  Arm still swollen next day (24+ hours later), redness and swelling spread to elbow and lower arm on second day.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat, aching 3-5 inches around site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: 20-25 mins following above 3 vaccines child started breaking out with rash on her forehead that was with the skin. Mother gave 5 l Benadryl. She continued to break out more. Returned to office in about 1 1/2 hours, where she was covered with hives from head to toes - T 98.8 P 100. Child awake, alert, no respiratory distress. Lungs clear, urticarial on face, body extremities. Resolved with 0-15 EPIPEN
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus, Rash, Rosacea
Clinical narrative: I started breaking out on my face within 1 month after the 1st injection, but it got some better and went away for awhile. When I got my 2nd injection that is when it started to get really bad on my face. As time has went on it has gotten worse and worse on my face. The skin doctor is trying to say that it is Rosacea, but I have NEVER had this before. The break out on my face reminds me of when my children had chicken pox. They are red, itchy and fester up to a pimple, and than bust. That's when others come up. They also itch really bad. It is so embarrassing, because they stay red all the time, and they are all over my face. I hope and pray that you all can help me, because I am at my wits end with this. Like I sa earlier, I never had this until I got those injections.
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Acne, Condition aggravated, Eczema, Herpes zoster, Oral herpes
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain, Pain of skin, Pruritus, Rash, Subcutaneous abscess
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Myalgia, Rash erythematous, Rash pruritic
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Arthralgia, Burning sensation, Erythema, Inflammation, Loss of personal independence in daily activities
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain in extremity, Pain of skin, Paraesthesia, Pruritus, Skin exfoliation
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 67.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Diffuse myalgias, pruritic erythematous rash of multiple sites
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling, itchiness at injection site
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: red and swollen vaccination spot, sore muscles, tired, headache, fever
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: red and swollen vaccination spot, sore muscles, tired, headache, fever
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: reports llllspecified patients were inadvertently administered doses of Rotateq that had been improperly stored; No additional adverse event; This non-valid spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On unknown date, the patients was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, (lot #1660947 and expiration date:16-FEB-2021 has been verifed to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)) (dose, dose number and anatomical location were not reported) for prophylaxis. No adverse symptoms were reported. The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature of 48 degrees of Fahrenheit (F) during a time frame of 1 hour. No previous temperature excursions. A data logger was involved.  This case was considered to be non-valid due to unspecified patients with no identifiers.