chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; received an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not provided. On 20-JUL-2020, the patients were vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S036636, expiration date 14-NOV-2021 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 15 to 46 (34.5) degrees Fahrenheit for 1 hour 22 minutes and 30 seconds. There was previous temperature excursion of 6 to 14 (9) degrees Fahrenheit for 52 minutes. Digital data logger was involved. The were no information how the sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored. No additional adverse effect was reported.
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient is not experiencing any adverse symptoms; a dose was given to a 23 year old after it was determined they did not have immunity to mmr or varicella; This spontaneous report as received from a nurse refers to a 23-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-JUL-2020, after it was determined they did not have immunity to measles, mumps, and rubella (MMR) or varicella, the 23-year-old patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S007074, expiration date not reported, but upon internal validation established as 06-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: itchy rash; SPOT LIKE RASH; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 2 weeks after receiving Shingrix, the patient experienced itchy rash and spot-like rash. On an unknown date, the outcome of the itchy rash and spot-like rash were unknown.   It was unknown if the reporter considered the itchy rash and spot-like rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient received second shingrix vaccine about 2 weeks ago prior to reporting date.  At the time of reporting the patient had an unusual itchy rash.  The patient reported that it was in weird spots, like on throat, a couple on belly.  It was not a bug bite and had not changed anything.  The patient was curious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperaesthesia, Incomplete course of vaccination, Product administered at inappropriate site
Clinical narrative: sensitive to the touch; red, rectangular area about two inches away; makes her think it wasn't given in the muscle; had the first dose in November; This case was reported by a consumer via call center representative and described the occurrence of touch sensitivity increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced touch sensitivity increased, erythema, vaccine administered at inappropriate site and incomplete course of vaccination. On an unknown date, the outcome of the touch sensitivity increased, erythema, vaccine administered at inappropriate site and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the touch sensitivity increased and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed a red, rectangular area about two inches away from where she was given the injection and there was no soreness when she moved her arm which makes her think it was not given in the muscle, which led to vaccine administered at inappropriate site. However, it was sensitive to the touch. The patient received 1st dose in November and did not received 2nd dose yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: RAB, TTOX, UNK
Symptoms: Arthralgia, Back pain, Pyrexia, Throat irritation, Vision blurred
Clinical narrative: knee pain; slight back pain; throat tickling; slight fever; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS SHOT) for prophylaxis and epinephrine for an unknown indication.   Concurrent medical conditions included antiphospholipid syndrome, diabetes and animal bite. Concomitant products included warfarin sodium (Warfarin), immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 1st dose of RabAvert, TETANUS SHOT and epinephrine at an unknown dose and frequency. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, fever, blurred vision, knee pain and back pain. On an unknown date, the outcome of the throat irritation, fever and blurred vision were recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, fever, blurred vision, knee pain and back pain to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The Rabavert was given along with tetanus and epinephrine and experiences throat tickling which goes away after a day.  The patient had slight fever and blurry vision both of which resolved after a day and had ongoing knee pain and ongoing slight back pain. The reporter consented to follow up. The patient receieved Rabavert for post exposure prophylaxis. This is 1 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: diagnosed with Shingles; back pain; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number 7XY2P, expiry date 24th January 2022) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, less than 3 weeks after receiving Shingrix, the patient experienced back pain and rash. On 27th July 2020, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the back pain and rash were unknown.   It was unknown if the reporter considered the shingles, back pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and visited his HCP and was diagnosed with Shingles.  The patient noticed some back pain several days before but thought it was due to playing golf until he noticed the rash.  The reporter made an appointment with his HCP and was diagnosed with Shingles. The HCP information was not provided.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B, Hepatitis B antibody negative, Hepatitis B antigen positive, Hepatitis B surface antibody negative, Hepatitis B virus test positive
Clinical narrative: after that was tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; booster dose of Engerix-B / tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; after a primary hepatitis B vaccination series and they came back borderline low (as reported); This case was reported by a physician via call center representative and described the occurrence of hepatitis b in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B, Engerix B and Engerix B, the patient experienced hepatitis b (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant) and therapy non-responder. On an unknown date, the outcome of the hepatitis b, vaccination failure and therapy non-responder were unknown.   It was unknown if the reporter considered the hepatitis b and vaccination failure to be related to Engerix B, Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had low levels of antibodies for hepatitis B virus, hence patient received booster dose of engerix B. After that the patient was tested and had a positive result for the disease. It was reported that the patient had been tested for antibodies after a primary hepatitis B vaccination series and they came back borderline low (as reported) and hence, the patient was given a booster dose of hepatitis B vaccination with Engerix B. After the Booster dose, (number of days not reported) the patient´s lab values revealed a positive HBs Ag value. The reporter consented to follow up.  This case was considered as suspected vaccination failure since the details regarding time to onset was unknown.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Therapy non-responder, Vaccination failure
Clinical narrative: after that was tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; booster dose of Engerix-B / tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; after a primary hepatitis B vaccination series and they came back borderline low (as reported); This case was reported by a physician via call center representative and described the occurrence of hepatitis b in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B, Engerix B and Engerix B, the patient experienced hepatitis b (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant) and therapy non-responder. On an unknown date, the outcome of the hepatitis b, vaccination failure and therapy non-responder were unknown.   It was unknown if the reporter considered the hepatitis b and vaccination failure to be related to Engerix B, Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had low levels of antibodies for hepatitis B virus, hence patient received booster dose of engerix B. After that the patient was tested and had a positive result for the disease. It was reported that the patient had been tested for antibodies after a primary hepatitis B vaccination series and they came back borderline low (as reported) and hence, the patient was given a booster dose of hepatitis B vaccination with Engerix B. After the Booster dose, (number of days not reported) the patient´s lab values revealed a positive HBs Ag value. The reporter consented to follow up.  This case was considered as suspected vaccination failure since the details regarding time to onset was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: 'sickness' in his stomach'; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was recovered/resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received but did not know which arm her husband received his, and that he only had the sickness in his stomach but was fine at the time of reporting. The reporter did not consent to follow up. The caller stated she did not had any HCP contact information. This case linked with US2020AMR149422, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR149422:same repoter
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old male patient received Dapatcel instead of Adacel, no AE; 12 year old male patient received Dapatcel vaccine, no AE; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old male patient who received a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 27-Jul-2020, the patient received a sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot 2032420 and expiry date: 23-May-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number of Adacel for this case (it was not administered).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: pain at injection site and body aches so severe she can not get out of bed
Age: 0.67
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: CSF test normal, Lumbar puncture normal, Magnetic resonance imaging normal, Strabismus, VIth nerve paralysis
Clinical narrative: Acute onset esotropia, left cranial nerve 6 palsy. Normal MRI and lumbar puncture with normal CSF studies. No other symptoms. Being monitored.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye pain, Fatigue, Headache, Neuralgia
Clinical narrative: A few days after injection patient developed fatigue, body aches. 1 week after injection patient developed a bad right sided headache that ache and burned and felt like nerve pain. She reports she is still tender over the right side of her face which is slowly resolving. She is also noticing eye pain on the right side. No rash
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: A few days after injection patient developed fatigue, body aches. 1 week after injection patient developed a bad right sided headache that ache and burned and felt like nerve pain. She reports she is still tender over the right side of her face which is slowly resolving. She is also noticing eye pain on the right side. No rash
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA, MMR, VARCEL
Symptoms: Developmental regression, Ear infection, Ear tube insertion, Emotional distress, Fall
Clinical narrative: Within two weeks my son developed chronic ear infections that lasted for 4 months. The only hope we had was to get him tubes after months of antibiotic oral and injected. He then regressed in his speech until he was basically mute. He started to fall down a lot from the ear infections to the point he could no longer walk. He became extremely irritable and inconsolable at times. He went from being a happy healthy boy meeting and exceeding all milestones. To a very sick little boy who regressed beyond comprehension and basically was unable to speak or walk. At 13 months old he started to crawl again because he couldn't walk without falling after every step.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA, MMR, VARCEL
Symptoms: Gait inability, Irritability, Malaise, Speech disorder
Clinical narrative: Within two weeks my son developed chronic ear infections that lasted for 4 months. The only hope we had was to get him tubes after months of antibiotic oral and injected. He then regressed in his speech until he was basically mute. He started to fall down a lot from the ear infections to the point he could no longer walk. He became extremely irritable and inconsolable at times. He went from being a happy healthy boy meeting and exceeding all milestones. To a very sick little boy who regressed beyond comprehension and basically was unable to speak or walk. At 13 months old he started to crawl again because he couldn't walk without falling after every step.
Age: 53.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: so far no reactions done. Vaccine given to Pt outside of recommendations (off lable)
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The vaccine DTaP was given instead of Tdap for the patients 11 year old vaccinations. No symptoms or signs of a reaction occurred in the office.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the nurse verified a total of 9 administration of improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, 0.5 ml, lot # T006792, expiration date 24-AUG-2021 (route of administration was not reported) for prophylaxis. The administered vaccine experienced temperature excursion of -13.5 degrees Celsius (C), -11.4 C, -1.8 C for 24 min, 27 min and 2 h 8 min. There was previous temperature excursion reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010434: US-009507513-2007USA010419: US-009507513-2007USA010252: US-009507513-2007USA010893: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T006792, expiration date 24-AUG-2021 (route of administration was not reported) for prophylaxis. The administered vaccine experienced temperature excursion of -13.5 degrees Celsius (C), -11.4 C, -1.8 C for 24 min, 27 min and 2 h 8 min. There was previous temperature excursion reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010434: US-009507513-2007USA010419: US-009507513-2007USA010252: US-009507513-2007USA010361: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; MMR II underwent a temperature excursion and was administered; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHA, lot # S025155, expiration date 13-AUG-2021 (strength, dose and route of administration were not provided) for prophylaxis. Administered dose of vaccines experienced the temperature excursion of 50 degrees Fahrenheit (F) for 1 hour and 46 minutes. Data logger was involved. There were no previous excursions reported. No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2007USA012014: US-009507513-2007USA012054: US-009507513-2007USA012060: US-009507513-2007USA012061: US-009507513-2007USA012124: US-009507513-2008USA000314: US-009507513-2008USA000326: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Soreness at the site of injection; Muscle Ache; Headache; Low grade fever / Fever; Chills; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2020, 8 hrs after receiving Shingrix, the patient experienced fever and chills. On 30th July 2020, the patient experienced injection site pain, muscle pain and headache. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, muscle pain, headache, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, headache, fever and chills to be related to Shingrix.  Additional details were provided as follows: The caller was a relative and GSK employee. The patient received Shingrix and had chills and low grade fever 99.5.  The patient had a fever of 100.5 the following morning along with headache, muscle ache and soreness at the site of injection.  The caller reported the patient took Acetaminophen prior to receiving the vaccine and again the next day.  Limited information was available. The reporter consented to follow up. Lot and expiration date was unavailable.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Incontinence, Syncope
Clinical narrative: Patient had two syncopal events in The office after administration of vaccine. Both within 15 minutes of administration patient soiled himself & was difficult to arouse.
Age: 67.0
Sex: F
Vaccine: CHOL
Symptoms: Miliaria, Rash, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: patient developed what she described as a heat rash first up her neck then on her arms and abdomen that was itchy at first, then turned into what she described as bumps that looked like bug bites and then it would blister.  She thought it was posion ivy at first, but it would return in cycles. She saw her doctor on July 29th and the doctor's office after researching concluded that she had developed chicken pox and prescribed Valtrex.  She picked up the Valtrex on 8/4, spoke to patient today on 8/6 and she says her symptoms have pretty much resolved now and she did not start the Valtrex, but picked it up in case the symptoms return
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Ear congestion, Fatigue, Headache, Injection site pain
Clinical narrative: Severe fatigue, headache, ear fullness, nasal drainage, nausea, weakness, itching hands and feet, pain at injection site.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pruritus, Rhinorrhoea
Clinical narrative: Severe fatigue, headache, ear fullness, nasal drainage, nausea, weakness, itching hands and feet, pain at injection site.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Confusional state, Dyspepsia, Fatigue
Clinical narrative: 8-10 hours after injection experienced extreme fatigue, broad-based joint pain. confusion. severe headache, burning and sharp stomach pain.  Symptoms lasted till 3 a.m. and then decreased gradually till 10 a.m. following day
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: 8-10 hours after injection experienced extreme fatigue, broad-based joint pain. confusion. severe headache, burning and sharp stomach pain.  Symptoms lasted till 3 a.m. and then decreased gradually till 10 a.m. following day
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; Nurse reports on 7/16/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, and previous drug reactions or allergies were not reported.    On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number S036635, which has been verified to be valid, and expiration reported and validated as 14-NOV-2021), as prophylaxis (dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided) (product storage error). The suspect vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not provided). Furthermore, it was reported that varicella virus vaccine live (oka/merck) (VARIVAX) was stored at different temperatures, one between minus 14 degrees Celsius (C) to minus 10 degrees C (minus 11.1 degrees C) for a time frame of 2 hours; another one between minus 9 degrees C to 8 degrees C (2.2 degrees C) for a time frame of 9 hours ad 30 minutes; another one between minus 14 degrees C to minus 10 degrees C (minus 9.8 degrees C) for a time frame of 2 hours and 30 minutes; and other one between minus 9 degrees C to 8 degrees C (0.4 degrees C) for a time frame of 3 hours, as recorded by digital data logger. Also, there was a previous temperature excursion between minus 9 degrees C to 8 degrees C (minus 6.1 degrees C) for a time frame of 8 hours. No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 20-Jul-2020  A pharmacist reported that a 21 year-old female (race and ethnicity not provided) was pregnant at the time of receiving HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.  On 20-Jul-2020, approximately 1 month after having been vaccinated with HEPLISAV-B, the patient contacted the pharmacist asking about information on HEPLISAV-B administration during pregnancy. The patient reportedly received her first dose of HEPLSIAV-B, was pregnant at the time, and was unsure of the exact gestational age.  The pharmacist was not the first-hand receiver of the call, and the injection was given by a different pharmacist. Further information was not available.   At the time of the report, the outcome of the event was not reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: MENB
Symptoms: Headache, Hypersensitivity, Myalgia
Clinical narrative: Headache; Myalgia; allergic reaction; This is a spontaneous report from a non-contactable other hcp. A 18-years-old patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and myalgia on an unspecified date with outcome of unknown. It was reported "I spoke to Dr (name provided) at 2 pm on 29Jul2020 -provided information from Custom SRD on headache and provided info from (name provided), et al. Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba) - A total of 94% of subjects reported resolution adverse events, including headache and myalgia, within 7 days. The other info shared was number of events of severe (limiting ADL) (this is adolescent patient ,18 y.o.(year old))" Dr wanted to know how long it lasted for the other 6% vaccineated in (state name provided) study ad how they were treated. He's treating the patient with Flexeril and ibuprofen 800 mg - patient went to ER last evening and the ER told the mother it was an "allergic reaction". He suggested they did that so the mother would not continue the vaccine series.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: specialist ordered titers for pneumonia and the results showed reduced immunity; This is a spontaneous report from a contactable pharmacist. A 9-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose (9 weeks, 4 months, 6 months and 12 months) for immunisation. The patient medical history and concomitant medications were not reported. The 9 year old female vaccinated previously with Prevnar 13 at 9 weeks, 4 months, 6 months and 12 months. Patient was seeing allergy specialist and specialist ordered titers for pneumonia and the results showed reduced immunity. Allergy specialist sent prescription for Prevnar13. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen reddened l deltoid
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: patient called the office today 8/6/20. states that he received the tdap vaccination on 7/29/20, states a couple of days later 7/31/20. he noticed his arm began to hurt. he noticed lump  and redness at the injection site. he stated he did not think anything of it. he had showed his wife today and she had called our office to inform us of the issue. wife states the lump was redden about 2 in by 3 in around. patient denied fever or any difficulty breathing. patient denies taking anything for the reaction. patient reports the site is better today, no worsening in redness or swelling. patient was educated on vaccine reaction and supportive home care and to report to the ER or call office with any changes they voiced understanding.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Nausea, headache, area of vaccine red & swollen, fatigue, low grade fever, shivering.  All lasted from 6 pm -noon .  This was my 2nd shingles vaccine of the 2.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, headache, area of vaccine red & swollen, fatigue, low grade fever, shivering.  All lasted from 6 pm -noon .  This was my 2nd shingles vaccine of the 2.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash
Clinical narrative: Rash on abdomen and chest - no drainage or bleeding, no pruritus or pain No other associated signs and symptoms
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Cold sweat, Skin warm
Clinical narrative: Pt. warm and clammy, lowered blood pressure 67/39
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Intense shivering, chills, body aches, headache, fatigue from about 8:00 p.m. the day of the vaccine (which was the 2nd dose of ). Effects lasted throughout the entire next day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The patient stated that initially the injection site was sore but was fine the next day. The day after the injection she stated the inner aspect of her upper arm is red, swollen, painful and warm. She said the area is about 6 inches long. She has full range of motion. The skin feels tight she said. She said the injection area on her deltoid is fine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin tightness
Clinical narrative: The patient stated that initially the injection site was sore but was fine the next day. The day after the injection she stated the inner aspect of her upper arm is red, swollen, painful and warm. She said the area is about 6 inches long. She has full range of motion. The skin feels tight she said. She said the injection area on her deltoid is fine.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Patient still experiencing pain and throbbing 22 days after injection.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: AFTER GETTING VACCINES PATIENT FAINTED FOR A COUPLE OF SECONDS. VITAL SIGNS BP:110/67 PULSE 114  10 MINUTES LATER 110/72 PULSE 128
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein, Culture urine, Febrile convulsion, Full blood count, Metabolic function test
Clinical narrative: Fever and febrile seizure
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, SARS-CoV-2 test, Urine analysis
Clinical narrative: Fever and febrile seizure
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allodynia, Lumbar puncture, Magnetic resonance imaging abnormal, Myelitis transverse, Pollakiuria
Clinical narrative: One week after vaccine, developed a band around lower abdomen allodynia. Over the course of a week, it extended down both legs, essentially to bottom of feet. Developed urinary frequency and hesitance. Hospitalized on Wednesday, July 22. MRI was done. Diagnosed longitudinally extensive transverse myelitis. It was idiopathic. Dr. felt  it was a reaction to vaccine. Treated with high dose of steroids. Made an excellent recovery.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary hesitation, Vaccination complication
Clinical narrative: One week after vaccine, developed a band around lower abdomen allodynia. Over the course of a week, it extended down both legs, essentially to bottom of feet. Developed urinary frequency and hesitance. Hospitalized on Wednesday, July 22. MRI was done. Diagnosed longitudinally extensive transverse myelitis. It was idiopathic. Dr. felt  it was a reaction to vaccine. Treated with high dose of steroids. Made an excellent recovery.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Low grade fever, myalgias, local pain and swelling
Age: 76.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Paralysis
Clinical narrative: The patient's son calls today to indicate the patient  develop paralysis a week later of the vaccination. He called requesting information about the vaccines and copy of the VARS to send it to  the lawyer.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was past expiration date. Expired on 7/8/2020, was given 7/20/2020. Called vaccine manufacturer and confirmed that dose would not be valid. Called Dad. No signs or symptoms of any adverse reaction to vaccine.
Age: 26.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Back pain, Irritability, Myalgia, Pain, Pain of skin
Clinical narrative: Severe rash on right arm, muscle soreness, skin soreness. Rash area was hot and sensitive to the touch. Full body aches especially lower back. Fever that reached 102.2. Irritability.
Age: 26.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Severe rash on right arm, muscle soreness, skin soreness. Rash area was hot and sensitive to the touch. Full body aches especially lower back. Fever that reached 102.2. Irritability.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Scan normal
Clinical narrative: I gave patient the immunization, she seemed fine. I walked away; My technician was ringing her and her mom out. I was answering questions for the mom; suddenly patient fell. We called first responders. All her vitals were okay. Mom stated she was taking her home instead of hospital. I call the mom this morning- she stated the family Dr did get scans for patient and everything came back clear and that patient was doing well.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Rash
Clinical narrative: Pt started with blanchable rash to hands and shoulders that is atypical of vaccination rashes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: The area around the injection site became red, inflamed, and tender/firm to the touch starting 1 day post vaccination. Patient consulted with pharmacist 2 days post vaccination stating that she was concerned since she did not have the same reaction to the 1st dose in the series. The pharmacist advised her to take an OTC NSAID, apply a cool compress if necessary, and to consult with her doctor if the reaction had not improved within 2 days. No further communication with the patient at this point.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash macular
Clinical narrative: PATIENT STATED HE HAS A MILD/SPLOTCHY RASH ON BOTH ARMS, AND CHEST/NECK AREA
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: Achy muscles, dizziness, nausea, tired
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: the next day the patient's arm was very swollen, red and warm to touch
Age: 13.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Dizziness, Headache, Neck pain, Syncope
Clinical narrative: vasovagal syncope, monitor/rest, dizzy/headache/neck pain remaining
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Palpitations
Clinical narrative: Fast and hard heart beat.  So much so my chest hurt until the next day. Called neighbor to stay with me until felt better.  Did not go in for treatment yet.  Just sent PCP message on portal. Will follow up with them
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: I experienced a strong headache, muscle aches, fatigue, nausea, and a low fever.  I treated it by taking Tylenol.  The symptoms were largely gone on the second day after the vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: in addition to pain/swelling at injection site, I have noted a large rash, approximately 3 inches in diameter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: on 8/3/2020  patient stated she started to have a localized reaction to her shot.  Area is red and swollen when the shot was given.  on 8/6/2020  the patient came by the pharmacy to let us know about the reaction.  I told the patient to take some benadryl and apply a compress to the area to help with the redness and swelling.  Patient's family care dr was notifed.  Also we are going to follow up with the patient in a few days to check on the progress of the reaction
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Nausea, Vomiting
Clinical narrative: Nausea and vomiting Hallucinations
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm became swollen and hard and warm to touch around the injection site and radiated down right above the elbow..Patient's primary physician was contacted and recommended patient take benadryl and tylenol or motrin for pain and follow up with doctor the following day if not improving. Patient was given choice to visit urgent care if needed.
Age: 73.0
Sex: F
Vaccine: MENB, MNQ, PPV, TDAP, VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Pain in extremity
Clinical narrative: PATIENT REPORTS PRONOUNCED TIREDNESS AND LOSS OF APPETITE FOR SEVERAL DAYS. PATIENT ALSO REPORTED ARM PAIN AND REDNESS ON LEFT ARM, THE SIDE WHERE THE SHINGRIX VACCINE WAS GIVEN.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Laboratory test, Malaise, Nausea
Clinical narrative: Pt stated they felt really sick, and nauseous. Extremely fatigued and flu like symptoms. Went to emergency room and was told pt experienced reaction to the vaccine. Was given medication for pain such as Toradol and Morphine and antihistamine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pt stated they felt really sick, and nauseous. Extremely fatigued and flu like symptoms. Went to emergency room and was told pt experienced reaction to the vaccine. Was given medication for pain such as Toradol and Morphine and antihistamine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Mass, Pain, Pyrexia
Clinical narrative: Lump 4 days Site rash  4 days Chills 2 days Aches 2 days Fever 2 days
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: PATIENT EXTREMELY FATIGUED, HAD TO LAY IN BED X24 HRS, HEADACHE
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: Patient presented  about a week after her vaccine  for erythema and heat, no fever or other symptoms.   She was treated with Keflex x 5 days to cover for cellulitis.  She then return to clinic on her 5th day of antibiotics with nearly unchanged presentation. She states there are no symptoms at this time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Gastrointestinal disorder, Pyrexia
Clinical narrative: Chills, fever, lightheadedness  GI side effects, fatigue
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Seizure
Clinical narrative: During administration of vaccine, the patient stated he was feeling dizzy. His skin became pale at that time. The LVN layed him down on the exam table and got him a wet rag for his forehead. He stated he was feeling better after a minute had passed. LVN advised him to continue to lay flat with feet up while she went to get the provider to assess him before he left. When NP & LVN returned to the room the patient's mother was standing beside him by the exam table. NP & LVN observed what is believed to be a seizure. The NP activated 911. Vitals repeated while waiting on EMS, all vitals WNL. No other episodes witnessed in clinic. EMS took patient to nearest ER.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Feeling hot, Lip swelling, Pain in extremity, Pruritus
Clinical narrative: Evening of July 22 was itchy, but about 11PM became unbearable and throughout the whole body. Severe itching from neck down to feet, after 2AM. Did not go to ER due to heavy rain and disabled daughter. Did not want to leave her. On July 23 AM became less itchy and more bearable. By late morning rash faded, wasn't as severe. No cause for alarm - I thought it was just one episode. By midnite the rash and itchy came back worse, again from my neck traveled down to my feet, chest, back, breast, waist, groin, buttocks, thighs, legs, feet. Also pain of hands and sole of feet were hot and burning. Like my body was on fire, no fever - I checked. Left side of lip became swollen and inside left cheek was swollen - like novocaine from dentist. Have not gone to dentist in a year. During the nite experienced breathing congestion like wheezing. July 24 afternoon rash somewhat faded and minor itching. Went to physician she established hives but would not accept reaction to MMR. She said it was detergent - I have not changed detergent in years and have not eatten any different diet. She advised Benadryl which I took for 5 days, hoping this reaction would not re-occur. Was given MMR since blood test showed rubella titer was low-.2 results. Nurse advised no adverse reaction and gave me a paper to read! I had these illness 60+ years ago!
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Respiratory tract congestion, Swelling face, Urticaria, Wheezing
Clinical narrative: Evening of July 22 was itchy, but about 11PM became unbearable and throughout the whole body. Severe itching from neck down to feet, after 2AM. Did not go to ER due to heavy rain and disabled daughter. Did not want to leave her. On July 23 AM became less itchy and more bearable. By late morning rash faded, wasn't as severe. No cause for alarm - I thought it was just one episode. By midnite the rash and itchy came back worse, again from my neck traveled down to my feet, chest, back, breast, waist, groin, buttocks, thighs, legs, feet. Also pain of hands and sole of feet were hot and burning. Like my body was on fire, no fever - I checked. Left side of lip became swollen and inside left cheek was swollen - like novocaine from dentist. Have not gone to dentist in a year. During the nite experienced breathing congestion like wheezing. July 24 afternoon rash somewhat faded and minor itching. Went to physician she established hives but would not accept reaction to MMR. She said it was detergent - I have not changed detergent in years and have not eatten any different diet. She advised Benadryl which I took for 5 days, hoping this reaction would not re-occur. Was given MMR since blood test showed rubella titer was low-.2 results. Nurse advised no adverse reaction and gave me a paper to read! I had these illness 60+ years ago!
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Feeling abnormal, Loss of consciousness
Clinical narrative: Pt. was being driven home in passenger seat & told father he was "feeling funny" & then lost consciousness for about 20 seconds. Father flagged down police driving by & EMT were called. EKG performed w/ normal results. Pt. scheduled appt w/ PCP but nothing was found.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Excessive eye blinking, Muscle twitching, Tic
Clinical narrative: Eye blinking progressing to twitching or tics that began within 1 day of the vaccines