chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VARIVAX on 1/31/2020; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 31-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route was not reported; lot # S024362, expiration date: 06-AUG-2021) for prophylaxis (was identified on 03-FEB-2020). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were unknown by the reporter). The vaccine underwent temperature excursion of 8.1 degrees Fahrenheit (F) for 42 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the patient inadvertently received a dose of PROQUAD instead of a dose of MMR II; the patient inadvertently received a dose of PROQUAD instead of a dose of MMR II; This spontaneous report was received from a medical assistant and refers to a 2 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 30-JAN-2020, due to human error, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002494 expiration date not reported, but upon internal validation established as 23-JUL-2020, for prophylaxis (dose, strength, and route of administration were not reported); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2012, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown), as prescribed and/or administered by a health care provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider at hospital for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated by a doctor for shingles. As a direct and proximate result of patient use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided. The lawyer considered the event to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pharmacist reported the patient received first dose of GARDASIL 9 on 10/9/2019. Pharmacist reported the patient is in the pharmacy now,  2/7/2020 and will be receiving second dose ofGARDASIL 9; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 07-FEB-2020, 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)(strength, dose, lot # , expiration date and route were not provided). Pharmacist reported that on 07-FEB-2020, the patient was currently in the pharmacy and would be receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R005341, expiration 06-DEC-2020) for prophylaxis.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; The patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a registered nurse referring to a patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On 03-FEB-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S008730 and expiration date on 23-JAN-2022, for prophylaxis (dose and anatomical location were not reported).  The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to a temperature excursion of above 9 degrees Celsius (°C) during a time frame of 1 hours 30 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional effects reported; a patient received her first GARDASIL 9 on 10-FEB-2019, second dose of GARDASIL 9 on 04-DEC-2019, and her third dose of GARDASIL 9 on 03-FEB-2020; Information has been received from a medical assistance, referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 02-OCT-2019, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. The patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) on 04-DEC-2019. On 03-FEB-2020, the patient was vaccinated with her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail and route were unknown) (lot # R028656 had been verified to be a valid number; expiration date was reported as 27-JUL-2021) (inappropriate schedule of product administration). No additional effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no ae; RECEIPT OF THREE DOSES OF ZOSTAVAX; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in January 2015, the patient was vaccinated with first dose of zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot/ batch number and expiry date were not reported) for prophylaxis. And on an unknown date in March 2015 and in October 2015, the patient was vaccinated with second and third dose of zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot/ batch number and expiry date were not reported) for prophylaxis from three separate facilities (extra dose administered). No adverse event was reported. No product quality complaint was reported. The outcome of the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; did not refrigerate it; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date in January 2020 (also reported as early January 2020), the patient picked up a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) one dosage form of lot number 1621934, expiry date 29-JAN-2022 (strength and route of administration was not reported) for prophylaxis at a pharmacy, did not refrigerate it, and brought it to her doctor's office for administration several days later (product storage error). The patient did not experience any symptoms (no adverse event). The lot did not undergo any temperature excursion previously and the call was not because of a data logger. There was no product quality complaint (PQC).
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnancy; Initial Report Received on 30-Jan-2020  This report was received from the HEPLISAV-B Pregnancy Registry.   A medical assistant reported to PPD's Registry Staff that they had a female patient (age and race not reported) who was 11 weeks pregnant and had received HEPLISAV-B (hepatitis B vaccine).   No medical history or concomitant medications were reported.  Information regarding HEPLISAV-B administration was not reported.    On 25-Nov-2019, the PPD Registry Staff received a call from a medical assistant (MA) with vaccinating provider. The MA reported they have a patient who is currently 11 weeks pregnant and she has received the HEPLISAV-B vaccine.  The MA informed me that the patient is interested in enrolling and they heard about the study from a package insert, and that she will provide the toll-free number to the patient and ask that she call and enroll herself. The MA was agreeable to a return call in 2 weeks if the patient has not called to enroll in the Registry."  The PPD Registry Staff attempted multiple phone call follow-ups to the HCP office but were unsuccessful.    The PPD Registry Staff reported that no further follow-up would be conducted by the Registry and permission for company to follow-up with the HCP office was not obtained.  At the time of the report, no adverse events were reported.   The action taken with HEPLISAV-B was not reported.    Company comment: The company assessed the pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B ; Sender's Comments: The company assessed the pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Nausea
Clinical narrative: Nausea; Diarrhea; Feeling Lightheaded; Body Aches; Shaking; Chills; Stomach Cramps; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported on 22-Jan-2020 a 25-year-old female employee received her first injection of HEPLISAV-B (Lot #933621). No concomitant vaccinations were administered. Two to three hours after injection, the employee experienced nausea with diarrhea without fever or rash, feeling lightheadedness, body aches, shaking, chills and stomach cramps. The employee took Excedrin Migraine (acetaminophen/aspirin/caffeine) and everything resolved.    None of the events were reported as serious.    Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Pain, Tremor
Clinical narrative: Nausea; Diarrhea; Feeling Lightheaded; Body Aches; Shaking; Chills; Stomach Cramps; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported on 22-Jan-2020 a 25-year-old female employee received her first injection of HEPLISAV-B (Lot #933621). No concomitant vaccinations were administered. Two to three hours after injection, the employee experienced nausea with diarrhea without fever or rash, feeling lightheadedness, body aches, shaking, chills and stomach cramps. The employee took Excedrin Migraine (acetaminophen/aspirin/caffeine) and everything resolved.    None of the events were reported as serious.    Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain upper, Chills, Nausea, Pruritus
Clinical narrative: Nausea; Stomach Cramps; Chills; Itching; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 42-year-old female employee received her first injection of HEPLISAV-B (Lot #933621) in Jan-2020. No concomitant vaccinations were administered. Two to three hours after injection, the employee experienced nausea, stomach cramps, chills, and itching. No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment. The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Erythema, Feeling hot, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Mild/Slight Rash at Injection Site; Itchiness; Redness due to Scratching; "Hot"; Feeling Nauseated; Sweating; Initial Report Received 30-Jan-2020 and 31-Jan-2020  On 25-Jan-2020, a physician reported that a female employee (approximate age 18 to 22 years) received her first injection of HEPLISAV-B (Lot #933621).  No concomitant vaccinations were administered.    One hour after vaccination, the employee reported mild/slight rash at injection site, itchiness, redness due to scratching, feeling nauseated, sweating, and "hot".    On 26-Jan-2020, the employee took Benadryl (diphenhydramine) at home and the events were all considered resolved.      None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Injection site rash, Nausea
Clinical narrative: Mild/Slight Rash at Injection Site; Itchiness; Redness due to Scratching; "Hot"; Feeling Nauseated; Sweating; Initial Report Received 30-Jan-2020 and 31-Jan-2020  On 25-Jan-2020, a physician reported that a female employee (approximate age 18 to 22 years) received her first injection of HEPLISAV-B (Lot #933621).  No concomitant vaccinations were administered.    One hour after vaccination, the employee reported mild/slight rash at injection site, itchiness, redness due to scratching, feeling nauseated, sweating, and "hot".    On 26-Jan-2020, the employee took Benadryl (diphenhydramine) at home and the events were all considered resolved.      None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Dose Was Administered Too Early; Received HEPLISAV-B as Third Dose in Engerix-B Series; Initial Report Received 06-Feb-2020  A pharmacist reported that a 21-year-old female with no known drug allergies received 2 doses of Engerix-B (dose 1 date not specified, dose 2 administered on 30-Dec-2019).  On 06-Feb-2020, Heplisav-B (Lot# 933622, Expiration date 01-Aug-2021) was administered.  No additional information was provided.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Sinusitis
Clinical narrative: Sinus infection; Spontaneous report received on 23DEC2019.  A pharmacist reported that a female consumer developed "sinus infection" (PT: Sinusitis), after completing the course of oral Vivotif for typhoid fever prophylaxis. On 19DEC2019, she had completed the course of Vivotif and then developed sinus infection. The pharmacist stated that she might developed the sinus infection on 22DEC2019 as she visited the doctor on that day and was prescribed with Zithromax (azithromycin) for sinus infection, which she had not started yet. It was reported that the pharmacist did not know if she had a history of sinus infection. Action taken with Vivotif with respect to the reported event was not applicable. She was not recovered from the reported event at the time of report.  The reporter considered the event of "sinus infection" was unrelated to Vivotif.  Company Comment: A consumer developed sinus infection after three days of completion of Vivotif course and then she was prescribed with Zithromax which she has not started taking yet. Considering the infectious nature of sinus infection, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer developed sinus infection after three days of completion of Vivotif course and then she was prescribed with Zithromax which she has not started taking yet. Considering the infectious nature of sinus infection, the causality of the event is assessed as not related to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: horrific pain at the injection site; swelling at the site of the shot/ both arms are swollen; lymphnodes in the underarm; both arms are sore; lymph nodes nodes in my underarms sore; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 25th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain. On an unknown date, the outcome of the injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain were unknown.   It was unknown if the reporter considered the injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had strange side effects. There was horrific pain and swelling at the site of the shot. But what was bad was that all the lymph nodes in my underarms, both arms are swollen and sore.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: experinceing all the side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had all the side effects. The reporter asked how long would this last.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain
Clinical narrative: soreness all over body; difficulty sleeping; This case was reported by a other health professional via sales rep and described the occurrence of generalized aching in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th November 2019, 1 days after receiving Shingrix, the patient experienced generalized aching and insomnia. On an unknown date, the outcome of the generalized aching and insomnia were unknown.   It was unknown if the reporter considered the generalized aching and insomnia to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but could be 62 or 63 years. Post vaccination the patient developed soreness all over body and difficulty sleeping. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The age at vaccination not provided. Injection site pain lasted for 1 to 2 days. For tolerances of 2nd dose of Shingrix, refer case US2020018231. The follow up consent was granted.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Malaise, Myalgia
Clinical narrative: Soreness at the injection site, muscle soreness over whole body, overall feeling fo malaise.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chills, Nausea, Photosensitivity reaction, Vomiting
Clinical narrative: c/o nausea, vomiting, temp 99.5 F, chills. Monitored for one hour. Vomiting subsided but continued to complain of nausea, photosensitivity and chills. Declined to be seen at ED. Accompanied home by friend.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Injection site urticaria, Pyrexia
Clinical narrative: Pt developed rash and hive at injection site. Pt developed fever of 101 the following am.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Aldolase normal, Antibody test negative, Blood creatine phosphokinase normal, Electromyogram abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Patient described increased R SCM tone that felt like "toritcollis" (patient is a retired MD) 2 weeks after vaccination, this decreased slightly over the following 2 weeks but at the time he developed concurrent extensor weakness in his neck to the point that he could not consistently keep it elevated. He was seen initially by ortho/PT who referred him to a neurologist. EMG done in January 2020 (i.e., 5 months after vaccination) was suggestive of a myopathic process. His symptoms have been stable for the last 4 months (no improvement or worsening), and he has had no associated pain, sensory alteration, or other axial/bulbar weakness.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Myopathy, Torticollis
Clinical narrative: Patient described increased R SCM tone that felt like "toritcollis" (patient is a retired MD) 2 weeks after vaccination, this decreased slightly over the following 2 weeks but at the time he developed concurrent extensor weakness in his neck to the point that he could not consistently keep it elevated. He was seen initially by ortho/PT who referred him to a neurologist. EMG done in January 2020 (i.e., 5 months after vaccination) was suggestive of a myopathic process. His symptoms have been stable for the last 4 months (no improvement or worsening), and he has had no associated pain, sensory alteration, or other axial/bulbar weakness.
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: sudden loss of hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 19-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided).On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from sudden loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced 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), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the 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 Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of sudden loss of hearing was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of sudden loss of hearing was considered to be disabling. Upon internal review, the event of sudden loss of hearing was considered to be medically significant.
Age: 63.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Arthralgia, Joint swelling, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: very lethargic; joints on the left side of her body (fingers, elbow, arm) were painful; joints on the left side of her body (fingers, elbow, arm) were swollen; finger pain/arm pain; could barely get out of bed for 3 days; This case was reported by a consumer via sales rep and described the occurrence of lethargy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Twinrix. On an unknown date, 1 day after receiving Shingrix and Twinrix, the patient experienced lethargy, mobility decreased, joint pain, swollen joints and pain in fingers. On an unknown date, the outcome of the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers were recovered/resolved.   The reporter considered the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers to be related to Shingrix. It was unknown if the reporter considered the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers to be related to Twinrix.  Additional details were provided as follows: In 2019 about 6 months ago, the patient received her second dose of Twinrix in her right arm and her first dose of Shingrix in her left arm. The patient woke up the morning very lethargic and could barely get out of bed for 3 days. The day after vaccination the joints on the left side of her body (fingers, elbow, arm) were very painful and swollen.  This progressed only on the left side of the body over a few days and would cause pain even while sleeping.  The patient started on an anti-inflammatory type diet to see if that would help.  The events took a few months to resolve but has fully resolved.  The patient believed that this reaction was due to the Shingrix and has refused to get the second dose of the vaccine. The patient received her 3rd dose of Twinrix without issue or adverse event. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: headache; Left side shoulder blade pain/ Left side of the body pain above the waist/ soreness; Neck pain; Injection site redness; Pain/ injection site pain; Rash / Injection site rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included paracetamol (Tylenol).   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site rash. On an unknown date, the patient experienced headache, shoulder blade pain and neck pain. On 16th August 2019, the outcome of the injection site erythema, injection site pain and injection site rash were recovered/resolved. On an unknown date, the outcome of the headache was unknown and the outcome of the shoulder blade pain and neck pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash, headache, shoulder blade pain and neck pain to be related to Shingrix.  Additional details were reported as follows: On 16th August 2019, the patient received the 1st dose of Shingrix on left delotid via intramuscularly and she experienced injection site redness, pain, and rash which were started about 2 hours after the vaccine and lasted for only 4 hours. The patient also experienced general adverse reactions like left side shoulder blade pain, neck pain, left side of the body pain above the waist. This events also resolved in a few hours. The patient was a diagnosed with arthritis for which she was taking Tylenol. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: headache; Left side shoulder blade pain/ Left side of the body pain above the waist/ soreness; Neck pain; Injection site redness; Pain/ injection site pain; Rash / Injection site rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included paracetamol (Tylenol).   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site rash. On an unknown date, the patient experienced headache, shoulder blade pain and neck pain. On 16th August 2019, the outcome of the injection site erythema, injection site pain and injection site rash were recovered/resolved. On an unknown date, the outcome of the headache was unknown and the outcome of the shoulder blade pain and neck pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash, headache, shoulder blade pain and neck pain to be related to Shingrix.  Additional details were reported as follows: On 16th August 2019, the patient received the 1st dose of Shingrix on left delotid via intramuscularly and she experienced injection site redness, pain, and rash which were started about 2 hours after the vaccine and lasted for only 4 hours. The patient also experienced general adverse reactions like left side shoulder blade pain, neck pain, left side of the body pain above the waist. This events also resolved in a few hours. The patient was a diagnosed with arthritis for which she was taking Tylenol. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling and mild erythema at the injection site from deltoid down to mid triceps, itchy, mild temp and fatigue
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Poor quality sleep
Clinical narrative: Headache around 10pm. Took an ibuprofen. In the middle of the night woke up with shivers and chills. Slept poorly. In the morning work up with nausea and sweats.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Dermatitis contact, Food allergy, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient developed contact dermatitis within hours of vaccination. Red, raised patches on her cheeks and legs and lighter pink dry patches on her arms and stomach.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash papular
Clinical narrative: Patient developed contact dermatitis within hours of vaccination. Red, raised patches on her cheeks and legs and lighter pink dry patches on her arms and stomach.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle spasms, Pain in extremity
Clinical narrative: patient reports within the first 24 hours of receiving the TDAP patient had extreme pain in left arm that radiates to neck down to fingers- patient has been having spasms. Patient saw Chiro- stated that it relieved the pain slightly and massages help as well. Patient has been taking advil as well as a hot pack when pain is not tolerable that helps. Patient scheduled to be evaluated
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Macule
Clinical narrative: dark, well-circumscribed, 1x2cm flat macule
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: chills, muscle aches, headache, temperature, pain at injection site, redness at injection site
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: chills, muscle aches, headache, temperature, pain at injection site, redness at injection site
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: large Red swollen warm to touch LUArm 16cm ht by 0.5cm wide. Was provided Dexamethasone 6mg IM or wait to fill antibiotic Keflex 500mg tid.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MENB
Symptoms: Expired product administered
Clinical narrative: Upon documentation post vaccine, I realized an error occurred. I didn't realize the vaccine expired 10 days prior, on 1/31/20. Told my supervisor immediately and was told to call patient's parent and explain what happened, and to have patient return for repeat vaccine. Patient mom understanding and she returned.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Candida infection, Dermatitis diaper, Erythema, Hand-foot-and-mouth disease, Injection site erythema
Clinical narrative: Large red ring, approximately 2 inches around injection site, followed by rash appearance bilaterally both thighs, only, hives, that itch Also, started diaper rash, then thrush, then diaper rash worsening  got better at few days shy of 2 month mark, 2nd shot given, dtap, within 4 hours, approximately 2 inch red ring reappears and bilaterally both thighs rash/hives that itch reappear.  24 hour mark, after seen by pa for reactions,  told hand foot mouth disease,  wait for fever. No fever appears,  recheck on day 8, after dtap, rash/hives are still present.  Told instead of benadryl,  give claritin and being sent to hematology
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Injection site rash, Pruritus, Rash, Urticaria
Clinical narrative: Large red ring, approximately 2 inches around injection site, followed by rash appearance bilaterally both thighs, only, hives, that itch Also, started diaper rash, then thrush, then diaper rash worsening  got better at few days shy of 2 month mark, 2nd shot given, dtap, within 4 hours, approximately 2 inch red ring reappears and bilaterally both thighs rash/hives that itch reappear.  24 hour mark, after seen by pa for reactions,  told hand foot mouth disease,  wait for fever. No fever appears,  recheck on day 8, after dtap, rash/hives are still present.  Told instead of benadryl,  give claritin and being sent to hematology
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Muscle fatigue, Myalgia, Oral herpes
Clinical narrative: Pain at injection site, severe headache, muscles aches & fatigue.  48 hours later I developed a cold sore.  I have had a cold sore before but it usually develops after an illness.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Received 2nd flu shot yesterday am,came to office this am having a febrile seizure,was given Diastat rectally and tylenol suppository and transported to hospital.Do not know outcome at this time.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pruritus, Rash
Clinical narrative: Patient woke up with itches and rashes today (11FEB2020). No difficulty breathing.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Condition aggravated, Dermatitis diaper, Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Within 15 minutes 3 ish inch red ring around injection site, rash/hives appeared bilaterally both thighs Had rash gone appropriately 4 days, from December 16 hib vaxx that initially started rash/hives, worsening of diaper rash within 2 hours  extreme emotional issues, 1 incident of abnormal neurological wobble, was told next day at pediatrician office by pa, that it was normal and rash/hives were hand foot mouth disease.  Seen on day 8 February 10 2020, for continued rash/hives, get better with 1 dose benadryl,  request dr place in file, adverse vaccine reactions,  2 separate times. Being referred to hematology
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Rash, Urticaria
Clinical narrative: Within 15 minutes 3 ish inch red ring around injection site, rash/hives appeared bilaterally both thighs Had rash gone appropriately 4 days, from December 16 hib vaxx that initially started rash/hives, worsening of diaper rash within 2 hours  extreme emotional issues, 1 incident of abnormal neurological wobble, was told next day at pediatrician office by pa, that it was normal and rash/hives were hand foot mouth disease.  Seen on day 8 February 10 2020, for continued rash/hives, get better with 1 dose benadryl,  request dr place in file, adverse vaccine reactions,  2 separate times. Being referred to hematology
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MMR, UNK, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy edd 3/26/2020
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MMR, UNK, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnancy edd 3/26/2020
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Dyspnoea, Rash
Clinical narrative: 5 mins after receiving Vaccine Flu booster., Pt started  having trouble breathing with blue lips and patches on skin. Unsure why Pt was sent by ambulance to the nearest Hospital.
Age: 33.0
Sex: F
Vaccine: HEP, UNK, VARCEL
Symptoms: Underdose
Clinical narrative: Patient accidentally was given pediatric dose rather than adult dose that she should have received
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vision blurred
Clinical narrative: Experienced chills, fever, sick to stomach feeling, nausea, blurry vision for two days. Did not seek medical attention. Symptoms diminished in 3 days.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Autoimmune disorder, Back pain, Crying, Gait disturbance, Hypoaesthesia
Clinical narrative: In 2016, she received an injectable flu vaccine (recorded as Afluria, Seqirus).  Within 2 hours of vaccination, she experienced "weak wobbly legs" that interfered with physical training.  Sxms lasted a few days, and resolved without treatment or medical eval.  . In 2017, she received an injectable flu vaccine (recorded as Fluarix, GSK).  Within 2 hours of vaccination, she experienced "weak wobbly legs" as well as back stiffness and aching.  Sxms lasted at least 1 week, and resolved without treatment or medical eval.  . In 2018, she received an injectable flu vaccine (recorded as Fluarix, GSK).  Within 2-3 hours of vaccination, she experienced "weak wobbly legs" and reports that this was the first time she connected the pattern to flu vaccine receipt.  Weakness was more pronounced and included paresthesia/numbness from feet up to knees.  Sxms were accompanied by back pain and stiffnes that was also more intense than previous episodes.  Sxms interfered with activity -- she reports crying while trying to go up steps.  Sxms resolved over approx. 2 weeks.  She did not seek medical care, based on previous bad experiences with medicine - but she now regrets not seeking consult.  2/5/20, Neuro Consult, Dr., MD - ASSESSMENT: Pt's sxs of weakness, numbness and gait instability after receiving flu vaccine suggests an autoimmune reaction directed against her nerves, possibly attachment to the myelin sheath.  She experiences these sxs shortly after vaccination (3-4 days) and lasted up to 3 weeks in duration with last vaccination.   She is back to her baseline now.   With her current presentation of vaccine sensitivity, I would recommend that she be exempt from flu shot prophylaxis in the future due to concerns of possibly developing a more serious condition, such as Guillain-Barre syndrome.   She is not immunocompromised otherwise.    Symptoms: PARESTHESIA OF SKIN(R202), LOW BACK PAIN(M545), WEAKNESS(R531).
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal stiffness, Pain, Paraesthesia
Clinical narrative: In 2016, she received an injectable flu vaccine (recorded as Afluria, Seqirus).  Within 2 hours of vaccination, she experienced "weak wobbly legs" that interfered with physical training.  Sxms lasted a few days, and resolved without treatment or medical eval.  . In 2017, she received an injectable flu vaccine (recorded as Fluarix, GSK).  Within 2 hours of vaccination, she experienced "weak wobbly legs" as well as back stiffness and aching.  Sxms lasted at least 1 week, and resolved without treatment or medical eval.  . In 2018, she received an injectable flu vaccine (recorded as Fluarix, GSK).  Within 2-3 hours of vaccination, she experienced "weak wobbly legs" and reports that this was the first time she connected the pattern to flu vaccine receipt.  Weakness was more pronounced and included paresthesia/numbness from feet up to knees.  Sxms were accompanied by back pain and stiffnes that was also more intense than previous episodes.  Sxms interfered with activity -- she reports crying while trying to go up steps.  Sxms resolved over approx. 2 weeks.  She did not seek medical care, based on previous bad experiences with medicine - but she now regrets not seeking consult.  2/5/20, Neuro Consult, Dr., MD - ASSESSMENT: Pt's sxs of weakness, numbness and gait instability after receiving flu vaccine suggests an autoimmune reaction directed against her nerves, possibly attachment to the myelin sheath.  She experiences these sxs shortly after vaccination (3-4 days) and lasted up to 3 weeks in duration with last vaccination.   She is back to her baseline now.   With her current presentation of vaccine sensitivity, I would recommend that she be exempt from flu shot prophylaxis in the future due to concerns of possibly developing a more serious condition, such as Guillain-Barre syndrome.   She is not immunocompromised otherwise.    Symptoms: PARESTHESIA OF SKIN(R202), LOW BACK PAIN(M545), WEAKNESS(R531).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swollen, painful, elevated in the area surrounding injection site
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Blood cortisol, Blood magnesium, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Adverse event- Diarrhea getting progressively worse. Stomach pain, nausea. Digestive inflammation. Sudden severe mental health crisis.  Tests- Multiple tests including xrays and CT Scan, stool sample, blood work. Treatment- Imodium- 2ce/day, Omeprazole- 1ce/ day, Prozac, Xanex.  Outcome- still pending.  As of 2/11/2020- stomach pain is almost gone,but still working on continued mental health and diarrhea issues
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Chest X-ray, Computerised tomogram abdomen, Diarrhoea, Electrocardiogram, Full blood count
Clinical narrative: Adverse event- Diarrhea getting progressively worse. Stomach pain, nausea. Digestive inflammation. Sudden severe mental health crisis.  Tests- Multiple tests including xrays and CT Scan, stool sample, blood work. Treatment- Imodium- 2ce/day, Omeprazole- 1ce/ day, Prozac, Xanex.  Outcome- still pending.  As of 2/11/2020- stomach pain is almost gone,but still working on continued mental health and diarrhea issues
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Gastrointestinal inflammation, Mental disorder, Metabolic function test, Nausea, Polymerase chain reaction
Clinical narrative: Adverse event- Diarrhea getting progressively worse. Stomach pain, nausea. Digestive inflammation. Sudden severe mental health crisis.  Tests- Multiple tests including xrays and CT Scan, stool sample, blood work. Treatment- Imodium- 2ce/day, Omeprazole- 1ce/ day, Prozac, Xanex.  Outcome- still pending.  As of 2/11/2020- stomach pain is almost gone,but still working on continued mental health and diarrhea issues
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Adverse event- Diarrhea getting progressively worse. Stomach pain, nausea. Digestive inflammation. Sudden severe mental health crisis.  Tests- Multiple tests including xrays and CT Scan, stool sample, blood work. Treatment- Imodium- 2ce/day, Omeprazole- 1ce/ day, Prozac, Xanex.  Outcome- still pending.  As of 2/11/2020- stomach pain is almost gone,but still working on continued mental health and diarrhea issues