chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: caller reported an improperly stored and adminitered MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.     On 13-AUG-2020, the patient received 1 dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S020963, expiration date: 07-JUL-2021; route was not reported) for prophylaxis (Product storage error). The vaccine was exposed to temperature 2 degree Celsius to 8 degree Celsius (8.4 degree Celsius) for 34 hours and 41 minutes; and above 9 degree Celsius (10.5 degree Celsius) for 6 hours. There was no previous temperature excursion. Data logger was involved.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002848, expiration date: 23-JAN-2022 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 50 minutes in the temperature between 6 degrees Fahrenheit (F) and 14 F (10.56 F), with a previous temperature excursion for 30 minutes between 6 F and 14 F (8.47 F). Digital Data Logger was involved.  There was no additional adverse event reported. The outcome of medication error was unknown.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer and the patient (pt) on 09-SEP-2020, referring to a 63 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-APR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster. The outcome of herpes zoster was unknown. The causality assessment between herpes zoster with zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient remained at the office for over 30 minutes with not obvious adverse effect; Medical Assistant calling to report accidental 4th dose of Gardasil 9 given to a patient. 1st dose given in 2012, 2nd and 3rd dose in 2014. 4th dose given today, then recognized as an error.; Medical Assistant calling to report accidental 4th dose of Gardasil 9 given to a patient. 1st dose given in 2012, 2nd and 3rd dose in 2014. 4th dose given today, then recognized as an error.; 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 history and concomitant medications were not provided.  On an unknown date in 2012, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, route of administration, dose and anatomical location were not reported) for prophylaxis. The patient received second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, route of administration, dose and anatomical location were not provided for both doses) on an unknown date in 2014 (inappropriate schedule of vaccine administration). On 11-SEP-2020 (reported as today), the patient received fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL (lot # 1637642, expiry date: 28-MAY-2022; route of administration and anatomical location were not reported) (extra dose administered). It was stated that system reported that the dose was needed and third dose was not seen in the file. Error was recognized after the fourth dose was given. The patient remained at the office for over 30 minutes with no obvious adverse effect. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; A patient who came to their office today received VAQTA that was expired on 08/23/2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 14-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml injection, lot # S021449 has been verified to be a valid lot number, expiration date 23-AUG-2020 (route of administration and injection site, frequency reported as once) for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: throat hurt; running a fever of 102; tired; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020 10:00, the patient received the 2nd dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced sore throat. In September 2020, the patient experienced fever and tiredness. On an unknown date, the outcome of the sore throat, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the sore throat, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: the case was reported by the mother of the patient. The age at vaccination was not reported but it could be 52 years or 53 years. The patient received 2nd Shingrix shot at 10:00 a.m. The patient was fine until dinnertime and then patient experienced throat hurt all the way to her Stomach. The patient was running a fever of 102 and was tired for almost 24 hours later.
Sex: U
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: Paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis was recovering/resolving.   The reporter considered the paralysis to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. Consumer reported that, friend of mine got paralyzed from flu shot six months recovering still had problems.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Headache
Clinical narrative: headaches; This case was reported by a other health professional via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, immediately after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had headaches ever since he received Shingrix and the flu vaccine on the same day.  The reporter asked was in different injection sites.
Sex: U
Vaccine: MENB
Symptoms: Hypoaesthesia
Clinical narrative: numbness in their arm; This case was reported by a physician via sales rep and described the occurrence of numbness of upper extremities in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter reported that the several patients received 1st dose of Bexsero and had numbness in their arm which persisted for about 2 weeks. No further information was available. This case has been linked with case ID US2020AMR185359 and US2019AMR199127, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR199127:same reporter US-GLAXOSMITHKLINE-US2020AMR185359:same reporter
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero.  Additional details were reported as follow: The age at vaccination was was not applicable. The reporter reported that the several patients received 1st dose of Bexsero and had injection site pain. No further information was available. This case has been linked with case ID US2020AMR185349 and US2019AMR199127, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR199127:same reporter US-GLAXOSMITHKLINE-US2020AMR185349:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Incorrect route of product administration, Inflammation
Clinical narrative: left arm was red; her left arm was/ hot; inflammation; given in the subcutaneously, instead of intramuscular/not sure of the needle gauge that was used to administer the injection; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (subcutaneous). In October 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced erythema of extremities, extremities hot feeling of and inflammation. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of, inflammation and intramuscular formulation administered by other route were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of and inflammation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was physician. She reported that she got her 1st Shingrix vaccine. She stated that when given the injection, it was given in the subcutaneously, instead of intramuscular, medication error, which led to intramuscular formulation administered by other route. The patient was not sure of the needle gauge that was used to administer the injection. She stated that after getting the injection, her left arm was red and hot, inflammation, for 1 to 2 weeks. The patient also stated that the she has received the second Shingrix vaccination and that, the two injections felt different, which was another reason why she thinks it was administered incorrectly
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Mobility decreased, Pain
Clinical narrative: a lot of bruising/bruising was 2 cm below the injection site; Can not mover the arm; Sore; This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5723N, expiry date 19th November 2022) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Boostrix (intramuscular). On 3rd September 2020, immediately after receiving Boostrix, the patient experienced pain. On 8th September 2020, the patient experienced contusion and mobility decreased. On an unknown date, the outcome of the contusion, mobility decreased and pain were unknown.   It was unknown if the reporter considered the contusion, mobility decreased and pain to be related to Boostrix.  Additional details were provided as follows: The pharmacist reported that a patient received 1st dose of Boostrix on left deltoid and right after the shot patient experienced sore. On Tuesday 8th September 2020 patient went back to the facility and reported to the pharmacist that there was a lot of bruising about 7 cm and also reported she could not move her arm.  Pharmacist was not aware if patient recovered from these events yet. After call was transferred, the Pharmacist stated the bruising was 2 cm below the injection site. The reporter consented to follow up. The case had been linked with US2020182601 and US2020182602 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182601:same reporter US-GLAXOSMITHKLINE-US2020182602:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Injection site bruising
Clinical narrative: bruise at injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In 2018, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The several family members were received Boostrix and experienced a 2 cm small bruise at injection site. This case was linked with case US2020182601 and US2020182599 as reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182601:same reporter US-GLAXOSMITHKLINE-US2020182599:same reporter
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 33-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   In March 1991, the patient received Hepatitis B vaccine (intramuscular) and INFLUENZA VACCINE. On an unknown date, between 1 and 2 weeks after receiving Hepatitis B vaccine and 1 week after receiving INFLUENZA VACCINE, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Hepatitis B vaccine.  Additional details were reported as follows: The case was reported by patient's wife. The patient had guillain barre syndrome approximately 1 to 2 weeks after receiving a flu shot and a hepatitis B vaccine in March 1991. The clinical staff associated guillain barre syndrome with the flu vaccine. Brand name and manufacturer of flu vaccine was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to influenza vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Extra dose administered, Swelling
Clinical narrative: received a 3rd dose of Shingrix; Swelling; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose was administered last year).   On 1st September 2020, the patient received the 3rd dose of Shingrix. On 1st September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In September 2020, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, this led to extra dose administered. The batch number was updated from 24KZZ to 24KZ7, as per sales data sheet. Less than 2 week after vaccination, the patient experienced redness and swelling. The reporter consented to follow up. No further clarifications were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020185498:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Inappropriate schedule of product administration
Clinical narrative: Upset Stomach; Headache; second dose of Sihngrix late, 7 months; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 7th February 2020, refer case US2020AMR186127).   On 14th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th September 2020, the patient experienced upset stomach and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the upset stomach and headache were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the upset stomach and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 75 or 76 year. The patient received second dose of Shingrix on right arm after 7 months, which led to lengthening of vaccination schedule. One day after vaccination, the patient experienced headache and upset stomach. The patient also reports taking Tylenol to relieve headache.  The patient gives consent to follow up with doctor. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR186127:same reporter
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Tdap on 9/15/2020 and he had already been given a Tdap on 5/21/2019.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Chills, Differential white blood cell count normal, Dizziness
Clinical narrative: Pt reported headache, chills, nausea, bodyaches and lightheadness about 1-3 hours after the injection.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count normal, Headache, Human chorionic gonadotropin normal, Metabolic function test normal, Nausea
Clinical narrative: Pt reported headache, chills, nausea, bodyaches and lightheadness about 1-3 hours after the injection.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Serum ferritin normal, Urine analysis normal
Clinical narrative: Pt reported headache, chills, nausea, bodyaches and lightheadness about 1-3 hours after the injection.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt felt sick to her stomach, vomited, and developed a fever 2 hours after getting vaccine. She had flu like symptoms for 36 hours following vaccine
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Neck pain, Peripheral swelling
Clinical narrative: arm is swollen and red. Pain radiates from neck to elbow.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Defaecation urgency, Insomnia, Malaise, Nausea
Clinical narrative: At 8pm felt very ill had to lie down.  Went to bed, awake most of night with severe nausea, some abdominal pain and though I never had diarrhea, felt when I went to bathroom for nausea that it would come out both ends.  Felt feverish but too  sick to get thermometer(live alone). Did vomit a few times but the nausea was severe.  At 4pm of the next day began to feel better, did not return to normal activities until the 26th.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: At 8pm felt very ill had to lie down.  Went to bed, awake most of night with severe nausea, some abdominal pain and though I never had diarrhea, felt when I went to bathroom for nausea that it would come out both ends.  Felt feverish but too  sick to get thermometer(live alone). Did vomit a few times but the nausea was severe.  At 4pm of the next day began to feel better, did not return to normal activities until the 26th.
Age: 17.0
Sex: F
Vaccine: FLU4, HEP, IPV, MNQ
Symptoms: Arthralgia, Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: (public health nurse) was administering the vaccines. Client said she needed a break before administering the other vaccines on the other arm. Client passed out and fell out of chair and hit her head fairly hard. Client was going in and out of consciousness for about 3-5 minutes, We called 911 and two EMS paramedics came to assess her. At this time, the client regained consciousness. EMS assessed her head and symptoms. Client was complaining of pain in the head that radiated down her shoulders. No severe neurological problems were identified. EMS helped the client get up onto a chair and decided she did not need transport to the emergency room. She was deemed stable to go home. We gave her juice boxes and sat with the client. Her aunt pulled up the car and both PHN's helped the client walk and ge3t into the car.
Age: 17.0
Sex: F
Vaccine: FLU4, HEP, IPV, MNQ
Symptoms: Nervous system disorder
Clinical narrative: (public health nurse) was administering the vaccines. Client said she needed a break before administering the other vaccines on the other arm. Client passed out and fell out of chair and hit her head fairly hard. Client was going in and out of consciousness for about 3-5 minutes, We called 911 and two EMS paramedics came to assess her. At this time, the client regained consciousness. EMS assessed her head and symptoms. Client was complaining of pain in the head that radiated down her shoulders. No severe neurological problems were identified. EMS helped the client get up onto a chair and decided she did not need transport to the emergency room. She was deemed stable to go home. We gave her juice boxes and sat with the client. Her aunt pulled up the car and both PHN's helped the client walk and ge3t into the car.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on arm near site of injection, resolved after several hours.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Vomiting
Clinical narrative: Chills and vomiting for 12-15 hours
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: swollen red tender at injection site, fever 101.7, chills, headache, tired, body aches
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: swollen red tender at injection site, fever 101.7, chills, headache, tired, body aches
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Starting following morning, fever of 103.5 . Fever stayed high for 12 hours, has gone down, but has lasted 3 days. Also very swollen hot red left arm. Lasting at least 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Tremor
Clinical narrative: got the vaccine around 10:45 am on 9/16    most of the day just had a sore arm at injection site went to bed and around 11:30 pm started feeling extremely cold- cold continued to worsen and my teeth began chattering really hard my whole body was shaking with cold- covered up with lots of blankets and a heating pad and took two advil cold and shaking went on for 20 minutes and finally subsided
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Injection site pain
Clinical narrative: Fever 100.9, weakness, body aches, joint pain, muscle pain, nausea, poor appetite, pain at site, chills
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever 100.9, weakness, body aches, joint pain, muscle pain, nausea, poor appetite, pain at site, chills
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse drug reaction, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 9-17-20 Seen by physician for evaluation left upper arm: there is large area of swelling and erythema on the outer deltoid area in location of immunization. slightly warm to touch but not significant, no palpable lymph nodes at this time. full ROM of arm Received tdap on 9-10-20 left deltoid. Yesterday on 9-16-20  woke up with rash and redness at injection site. Today redness is larger and warm to touch.  she is likely reacting to something in the Adacel shot, will give her prednisone as below for 5 days use ibuprofen for pain and Benadryl for itching
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Pt had shingrix vaccine given in her left arm but within a few days, developed rash on right arm with blisters. Rash has healed since then, but little dots of rash still visible. Pt denies any pain but experienced itching.  Pt states she had the same rash appear on her waist a few years back but did not know it was a case of shingles. Did not get evaluated at that time and did not get evaluated at this time.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Mother reported patient developed fever of 100.9 on 5/7/2020; went to ER on 5/8/2020 for fever and rash that started on left thigh at location of injection and spread to arms/legs/torso.  Had telehealth visit on 5/8 for rash/fever; recommended by provider to return to ER for worsening rash as provider was not able to adequately visualize via telehealth. On 5/11/2020 patient had follow up visit for continued rash/fever.  Discussed with mother today regarding duration of events; she reports that rash and fever resolved after about 2-3 weeks.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: none did not administer 2nd dose
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Cardiac telemetry, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: vaccine administered at 1600; at 1630 epinephrine 0.3 mg administered x1 dose to right thigh by other provider, 1635 EMS was called, 1637 pt's husband was notified, 1647 EMS arrived, 1650 pt left clinic via wheelchair with EMS.  Pt remained awake, alert, oriented and talking normal throughout this time.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Troponin I
Clinical narrative: vaccine administered at 1600; at 1630 epinephrine 0.3 mg administered x1 dose to right thigh by other provider, 1635 EMS was called, 1637 pt's husband was notified, 1647 EMS arrived, 1650 pt left clinic via wheelchair with EMS.  Pt remained awake, alert, oriented and talking normal throughout this time.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pruritus, Skin exfoliation, Wound
Clinical narrative: ITCHY, REDNESS, FLAKING SKIN,  LOWER LEGS, BILATERAL. (LOWER RIGHT LEG WOUND OPEN, YELLOW  AT BOTTOM OF WOUND. REDNESS FLAKING  ALSO PRESENT, DISTAL ARMS AND BACK.  SKIN APPEARS RED WITH WHITE FLAKES .          TX: EMERGENCY ROOM VISIT; CLINDAMYCIN ORAL  AND MEDROL ORAL
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain in back and throughout the body developing a week after injection.
Age: 66.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Fever 101.7 chills, nausea, malaise, injection site redness and swelling  Took 3 rounds of Advil, rest  and hydration  2 days later still malaise , no fever
Age: 66.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.7 chills, nausea, malaise, injection site redness and swelling  Took 3 rounds of Advil, rest  and hydration  2 days later still malaise , no fever
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Hypotension, Muscular weakness, Visual impairment
Clinical narrative: Low blood pressure about 7-10 minutes after injection, resulting in faded vision, loss of balance, and muscle weakness. Avoided passing out. Sat down for about 10 minutes and symptoms cleared up, with some visual spotting and muscle weakness remaining for an additional 20 minutes.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Inflammation, Swelling
Clinical narrative: FACIAL / LIP INFLAMMATION WITHOUT THROAT SWELLING TREATED WITH DIPHENHYDRAMINE - SWELLING SUBSIDED
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Erythema, Injection site joint inflammation, Magnetic resonance imaging abnormal, Mobility decreased
Clinical narrative: On Sept 30, 2019, I received the flu injection by a temporary staff person, working at the clinic. Waited to be released for possible reaction.  Went home and within a couple hours upper arm became very painful, never had that much pain from previous flu injections) so placed ice on upper arm and took Tylenol.  By 5 pm I could not lift my arm and had extreme pain running down arm and into the fingers. When I took my shower later that evening I noticed the bandage was placed high up shoulder near joint. I found that very unusual. Took more pain reliever and another ice pack and went to bed. Continued ice and pain reliever throughout Sat, Oct. 1.  At 9:07 pm I contacted Dr., my  primary physician, via the messaging system and relayed what I was experiencing and my fear there was a possible injury to my shoulder.  His response: Having a bad reaction, which is not unusual. Ice and take Tylenol; pain should be gone within 3 days. See immune responses like this quite often.  Rest assure the shoulder joint is fine.  Sunday there was swelling and redness.  On Monday, Oct 5 I called the clinic and appointment was scheduled to see NP, as Dr. was on vacation.  Appointment was scheduled for Oct. 9 @ 2:20 pm.  NP and the staff manager, both examined the arm and stated injection was definitely given in or near the joint.  An ultrasound was scheduled for the next morning at the Medical Center, Results:  ultrasound was normal, no signs of fluid collection, no foreign body. Should resolve in a week.  Pain continued and I decided to get appointment with my Orthopedic Doctor. Appt:  Oct. 28, 2019.  X-ray was taken.  Diagnoses:  Inflammation of shoulder and Frozen Shoulder.  Referred to Physical Therapist for the Frozen shoulder.  Physical therapy began Oct. 29 with PT  (seven days).  Returned for follow-up visit with Dr. (Nov 11)  with continued pain.  Ordered MRI . MRI was done on Nov 21 and follow up visit on Nov 25 with Dr., diagnoses Torn Rotator Cuff.  Referred to Dr. specialist in shoulder problems at same clinic with appointment on Dec. 3, 2019.  Was given a cortisone injection, which helped some.  Pain continued to get worse again and Mar 3, 2020 another injection was given and surgery was recommended.  Then COVID 19 stopped all elective surgeries.  Another injection given on May 26 to help with pain until surgery could be done.  Finally, elective surgeries could be done and on July 2 saw Dr. again for pre-surgery visit and scheduled surgery for July 22, 2020.  July 14, 2020, Pre-Op Clearance Exam completed.  July 22, 2020 surgery was performed.  July 28 visit with PA for suture removal and PT instructions to be performed at home.  Aug 18 first post-op exam and continued At-home PT with additional instructions.  Next appointment set for Oct. 19, 2020 for evaluation of shoulder.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis, Product administered at inappropriate site, Rotator cuff syndrome, Shoulder operation
Clinical narrative: On Sept 30, 2019, I received the flu injection by a temporary staff person, working at the clinic. Waited to be released for possible reaction.  Went home and within a couple hours upper arm became very painful, never had that much pain from previous flu injections) so placed ice on upper arm and took Tylenol.  By 5 pm I could not lift my arm and had extreme pain running down arm and into the fingers. When I took my shower later that evening I noticed the bandage was placed high up shoulder near joint. I found that very unusual. Took more pain reliever and another ice pack and went to bed. Continued ice and pain reliever throughout Sat, Oct. 1.  At 9:07 pm I contacted Dr., my  primary physician, via the messaging system and relayed what I was experiencing and my fear there was a possible injury to my shoulder.  His response: Having a bad reaction, which is not unusual. Ice and take Tylenol; pain should be gone within 3 days. See immune responses like this quite often.  Rest assure the shoulder joint is fine.  Sunday there was swelling and redness.  On Monday, Oct 5 I called the clinic and appointment was scheduled to see NP, as Dr. was on vacation.  Appointment was scheduled for Oct. 9 @ 2:20 pm.  NP and the staff manager, both examined the arm and stated injection was definitely given in or near the joint.  An ultrasound was scheduled for the next morning at the Medical Center, Results:  ultrasound was normal, no signs of fluid collection, no foreign body. Should resolve in a week.  Pain continued and I decided to get appointment with my Orthopedic Doctor. Appt:  Oct. 28, 2019.  X-ray was taken.  Diagnoses:  Inflammation of shoulder and Frozen Shoulder.  Referred to Physical Therapist for the Frozen shoulder.  Physical therapy began Oct. 29 with PT  (seven days).  Returned for follow-up visit with Dr. (Nov 11)  with continued pain.  Ordered MRI . MRI was done on Nov 21 and follow up visit on Nov 25 with Dr., diagnoses Torn Rotator Cuff.  Referred to Dr. specialist in shoulder problems at same clinic with appointment on Dec. 3, 2019.  Was given a cortisone injection, which helped some.  Pain continued to get worse again and Mar 3, 2020 another injection was given and surgery was recommended.  Then COVID 19 stopped all elective surgeries.  Another injection given on May 26 to help with pain until surgery could be done.  Finally, elective surgeries could be done and on July 2 saw Dr. again for pre-surgery visit and scheduled surgery for July 22, 2020.  July 14, 2020, Pre-Op Clearance Exam completed.  July 22, 2020 surgery was performed.  July 28 visit with PA for suture removal and PT instructions to be performed at home.  Aug 18 first post-op exam and continued At-home PT with additional instructions.  Next appointment set for Oct. 19, 2020 for evaluation of shoulder.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Ultrasound scan normal, X-ray limb abnormal
Clinical narrative: On Sept 30, 2019, I received the flu injection by a temporary staff person, working at the clinic. Waited to be released for possible reaction.  Went home and within a couple hours upper arm became very painful, never had that much pain from previous flu injections) so placed ice on upper arm and took Tylenol.  By 5 pm I could not lift my arm and had extreme pain running down arm and into the fingers. When I took my shower later that evening I noticed the bandage was placed high up shoulder near joint. I found that very unusual. Took more pain reliever and another ice pack and went to bed. Continued ice and pain reliever throughout Sat, Oct. 1.  At 9:07 pm I contacted Dr., my  primary physician, via the messaging system and relayed what I was experiencing and my fear there was a possible injury to my shoulder.  His response: Having a bad reaction, which is not unusual. Ice and take Tylenol; pain should be gone within 3 days. See immune responses like this quite often.  Rest assure the shoulder joint is fine.  Sunday there was swelling and redness.  On Monday, Oct 5 I called the clinic and appointment was scheduled to see NP, as Dr. was on vacation.  Appointment was scheduled for Oct. 9 @ 2:20 pm.  NP and the staff manager, both examined the arm and stated injection was definitely given in or near the joint.  An ultrasound was scheduled for the next morning at the Medical Center, Results:  ultrasound was normal, no signs of fluid collection, no foreign body. Should resolve in a week.  Pain continued and I decided to get appointment with my Orthopedic Doctor. Appt:  Oct. 28, 2019.  X-ray was taken.  Diagnoses:  Inflammation of shoulder and Frozen Shoulder.  Referred to Physical Therapist for the Frozen shoulder.  Physical therapy began Oct. 29 with PT  (seven days).  Returned for follow-up visit with Dr. (Nov 11)  with continued pain.  Ordered MRI . MRI was done on Nov 21 and follow up visit on Nov 25 with Dr., diagnoses Torn Rotator Cuff.  Referred to Dr. specialist in shoulder problems at same clinic with appointment on Dec. 3, 2019.  Was given a cortisone injection, which helped some.  Pain continued to get worse again and Mar 3, 2020 another injection was given and surgery was recommended.  Then COVID 19 stopped all elective surgeries.  Another injection given on May 26 to help with pain until surgery could be done.  Finally, elective surgeries could be done and on July 2 saw Dr. again for pre-surgery visit and scheduled surgery for July 22, 2020.  July 14, 2020, Pre-Op Clearance Exam completed.  July 22, 2020 surgery was performed.  July 28 visit with PA for suture removal and PT instructions to be performed at home.  Aug 18 first post-op exam and continued At-home PT with additional instructions.  Next appointment set for Oct. 19, 2020 for evaluation of shoulder.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling and pain in left shoulder. The patient went to the Emergency room the following morning (9/17) for the pain and swelling. The hospital administered a pain injection to help with the pain. The patient ad provider states they are doing okay and stable, although still some swelling and pain.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: shoulder pain after vaccine, hurts to lift arm.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Feeling cold, Musculoskeletal chest pain, Myalgia, Pyrexia
Clinical narrative: At 6:30 pm on the date of injection, I became cold with chills and shivering.  Soon after, I had intense muscular pain in my upper, middle, and lower back.  My spine and rib cage also hurt immensely.  I took 1000mg of Tylenol and my usual dose of 10mg oxycodone and went to bed.  My fever was about 100.4 and rose to 101.6 within a couple hours but never went higher.  At 8:00 am, I woke up with very little pain and no fever, but did have the dry heaves for about 10 minutes.  As the day went on, the symptoms pretty much disappeared and I was eating normally with no side effects from the day before.  Within one day, September 3, I had completely gone back to my regular schedule.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Retching, Spinal pain
Clinical narrative: At 6:30 pm on the date of injection, I became cold with chills and shivering.  Soon after, I had intense muscular pain in my upper, middle, and lower back.  My spine and rib cage also hurt immensely.  I took 1000mg of Tylenol and my usual dose of 10mg oxycodone and went to bed.  My fever was about 100.4 and rose to 101.6 within a couple hours but never went higher.  At 8:00 am, I woke up with very little pain and no fever, but did have the dry heaves for about 10 minutes.  As the day went on, the symptoms pretty much disappeared and I was eating normally with no side effects from the day before.  Within one day, September 3, I had completely gone back to my regular schedule.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received both vaccines and reports immediate swelling/pain of right arm; presented the next day with erythema to full upper arm, ttp, no fever,
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Additional Pediarix given. patient had already received two doses of Pentacel and one dose of Pediatrix, so did not need the additional dose of Pediarix.  Moreover, it was given only two weeks after the prior Pediarix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Two days later patient had red area 71/2cm by 71/2cm area, warm to the touch. Provider sent prescription Loratadine 5mg children's chewable tablets, and children's Benadryl cream. Gave child dose of 2.5mL of children's benadryl in office and ice pack. Patient no fever or report any other symptoms.
Age: 24.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: The patient was vaccinated with improperly stored vaccine of PNEUMOVAX23; This spontaneous report was received from a nurse, referring to a 24 years old patient of unknown gender. The patient´s pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with an improperly stored doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliters, lot number: T009744 and expiration date: 28-JAN-2022 (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis.  The improperly stored of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion of 48.39 Fahrenheit degrees (°F) for 1 hour and 45 minutes without a previous temperature excursions. It was confirmed that a digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 14-JAN-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the 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 the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 07-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the 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 the event shingles was not recovered. The causality assessment was considered as related by the lawyer.