chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Had a reaction to the 1st; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The patient was told that they would have no reaction even though the patient had reaction to the 1st dose. It was told that it was very unusual and the patient thought that they need to educate health care people much better as in talking to others and had learned that was their experience as well. The patient had lupus but was told that it did not matter. For tolerance of 2nd dose of Shingrix, refer case US2019AMR223516.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Injection site infection
Clinical narrative: Extreme chills and shaking for several hours the evening I received the injection, followed by fever.  Temperature ranged from 100 to 102.  I experienced nausea in waves, but did not throw up.  The fever continued the next day.  The nausea continued for two days, on and off.  I had a bad headache for 3 days, starting the evening I received the injection.  The pain and redness in my upper left arm (injection site) worsened 2 - 3 days after the vaccine was received.  I went to a doctor who diagnosed a skin infection at the site of the infection because the area was hot to the touch, very red, and swollen. The antibiotics he prescribed caused severe stomach pain for two weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Extreme chills and shaking for several hours the evening I received the injection, followed by fever.  Temperature ranged from 100 to 102.  I experienced nausea in waves, but did not throw up.  The fever continued the next day.  The nausea continued for two days, on and off.  I had a bad headache for 3 days, starting the evening I received the injection.  The pain and redness in my upper left arm (injection site) worsened 2 - 3 days after the vaccine was received.  I went to a doctor who diagnosed a skin infection at the site of the infection because the area was hot to the touch, very red, and swollen. The antibiotics he prescribed caused severe stomach pain for two weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Extreme chills and shaking for several hours the evening I received the injection, followed by fever.  Temperature ranged from 100 to 102.  I experienced nausea in waves, but did not throw up.  The fever continued the next day.  The nausea continued for two days, on and off.  I had a bad headache for 3 days, starting the evening I received the injection.  The pain and redness in my upper left arm (injection site) worsened 2 - 3 days after the vaccine was received.  I went to a doctor who diagnosed a skin infection at the site of the infection because the area was hot to the touch, very red, and swollen. The antibiotics he prescribed caused severe stomach pain for two weeks.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No symptoms reported.; one (1) of 5 patients inadvertently received dose of GARDASIL 9 in error for another unspecified vaccine/Patient is between 6 to 9 monlhs old/GARDASIL 9 was selected as human error, not confusion.; one (1) of 5 patients inadvertently received dose of GARDASIL 9 in error for another unspecified vaccine/Patient is between 6 to 9 monlhs old/GARDASIL 9 was selected as human error, not confusion.; This spontaneous report has been received from a medical assistant referring to a 6 to 9 months old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 17-DEC-2019, the patient was inadvertently received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: 1602284, expiration date: 26-SEP-2021; frequency, route and dose details were unknown) for prophylaxis in error for another unspecified vaccine (product administered to patient of inappropriate age and wrong product administered). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was selected as human error, not confusion. No symptoms reported.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 27 years old patient was inadvertently administered one dose of PROQUAD; No additional adverse symptoms; This spontaneous report has been received from a medical assistant concerning a 27-year-old patient of unknown gender. The patient's past drug and pertinent medical history,drug reactions or allergies, as well as the concomitant medications, were not provided.   On 20-DEC-2019, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, (recombinant Human albumin (rHA)) (PROQUAD) 1 dosage form (lot number S000623, expiration date reported as 06-JUL-2020) as prophylaxis ( concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  No adverse effects were reported for the patient.   The patient's outcome from the reported events was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, he was treated and hospitalized for shingles. As a direct and proximate of the zoster vaccine live (ZOSTAVAX), the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Demyelination, Hypoaesthesia, Myelitis transverse, Neuropathy peripheral, Paraesthesia
Clinical narrative: bilateral lower extremity paresthesias; transverse myelitis; CNS demyelination; idiopathic neuropathy; poliomyelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 06-JUN-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered numbness in the legs and experienced multiple hospitalizations where she was ultimately diagnosed with bilateral lower extremity paresthesia, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis. As a direct and proximate result of vaccine live(ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using vaccination. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccine live(ZOSTAVAX) patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcoem of events was considered as not recovered. The reporter claimed the events were related to zoster vaccine live(ZOSTAVAX).   Upon internal review, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis were determined to be medically significant. All the events were considered as disabled according to the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Poliomyelitis
Clinical narrative: bilateral lower extremity paresthesias; transverse myelitis; CNS demyelination; idiopathic neuropathy; poliomyelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 06-JUN-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered numbness in the legs and experienced multiple hospitalizations where she was ultimately diagnosed with bilateral lower extremity paresthesia, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis. As a direct and proximate result of vaccine live(ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using vaccination. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccine live(ZOSTAVAX) patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcoem of events was considered as not recovered. The reporter claimed the events were related to zoster vaccine live(ZOSTAVAX).   Upon internal review, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis were determined to be medically significant. All the events were considered as disabled according to the reporter.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; One patient recieved an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 6-month-old infant of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 19-NOV-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) via route defaulted to oral for prophylaxis (lot # R033251 and expiration date: 29-JUN-2020) (product storage error). The administered dose of the vaccine experienced temperature excursion at 32.36 degree Farenheit for a timeframe of 134 hours. There were no previous temperature excursion reported. No symptoms were reported. The call was due to digital data logger. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported.; his son received the second dose of his GARDASIL 9 shot in June of 2019 (15 months after his first dose); This spontaneous report was received from a consumer referring to his son as a male patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    In March 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis. In June 2019 (reported as 15 months after his first dose), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  In December 2019 (reported as six months after his second dose), the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis.  No adverse effects were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Computerised tomogram, Herpes zoster, Incomplete course of vaccination, Nodule
Clinical narrative: I now have internal shingles; Lump on neck and clavicle; Burning lump; Itching lump; has not had dose 2 yet.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingrix at an unknown dose. In December 2019, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nodule, burning sensation, pruritus and incomplete course of vaccination. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles, nodule, burning sensation, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, nodule, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had internal shingles. The patient reported that, 7 days ago from the date of reporting, the patient had burning and itching lump on her neck and clavicle. The day before reporting, the patient had CT scan with results pending. The patient stated that, till the time of reporting, did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: I now have internal shingles; Lump on neck and clavicle; Burning lump; Itching lump; has not had dose 2 yet.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingrix at an unknown dose. In December 2019, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nodule, burning sensation, pruritus and incomplete course of vaccination. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles, nodule, burning sensation, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, nodule, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had internal shingles. The patient reported that, 7 days ago from the date of reporting, the patient had burning and itching lump on her neck and clavicle. The day before reporting, the patient had CT scan with results pending. The patient stated that, till the time of reporting, did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: allergic reaction; red itchy rash/red bump; red itchy rash; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced allergic reaction, itchy rash and red rash. On an unknown date, the outcome of the allergic reaction, itchy rash and red rash were unknown.   It was unknown if the reporter considered the allergic reaction, itchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient at clinic who developed a red itchy rash like bumps 24 hours after his first shingles shot that occurred all over his body, including arms and stomach and not face, throat, or mouth.  The reporter was wondering if this contraindicates him from receiving the second dose. Based on the recommendation to not receive it if you had an allergic reaction to a previous injection, would assume that patient should not get it, but would like to confirm.
Age: 0.58
Sex: F
Vaccine: MEN
Symptoms: Adverse drug reaction, Brain injury, Impaired driving ability, Loss of personal independence in daily activities, Speech disorder
Clinical narrative: Brain damage; speech impaired; Can't tie a shoe, can't drive, can't cook; horrible reaction to a vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of brain damage in a 25-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced brain damage (serious criteria GSK medically significant), speech impairment nos, loss of personal independence in daily activities and adverse drug reaction. On an unknown date, the outcome of the brain damage, speech impairment nos, loss of personal independence in daily activities and adverse drug reaction were unknown.   The reporter considered the brain damage to be related to Meningococcal B vaccine. It was unknown if the reporter considered the speech impairment nos, loss of personal independence in daily activities and adverse drug reaction to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The reporter reported that, the patient had a horrible reaction to a vaccine at 7 months old. At the time of reporting, the patient was 25 years old and was could not tie a shoe, could not drive and cook, and speech impaired. The reporter stated that, the patient had brain damage from  vaccine. The reporter reported that, Mercury, Formaldehyde and many other toxins should not be allowed to be injected into our bodies. The reporter stated that, the patient's normal life was robbed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Nausea
Clinical narrative: experienced nausea; experienced tight chest; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 2nd January 2022) for prophylaxis.   On 3rd December 2019, the patient received the 1st dose of Shingrix. On 3rd December 2019, less than a day after receiving Shingrix, the patient experienced nausea and chest tightness. On an unknown date, the outcome of the nausea and chest tightness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and chest tightness to be related to Shingrix.  Additional case details were reported as follows: The batch number was update from C453 to JC453, as per sales data sheet. The patient received Shingrix and experienced nausea and a tight chest. The reporter consented to follow up. Permission was provided for follow up. The patient discussion with her physician asked her to talk to her doctor and told her the patient would hold off on the second shot until they are confident she should take it.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: Fatigue; Extreme Body Pain; to not being able to do normal activities; Headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On 13th December 2019, 1 days after receiving Shingrix, the patient experienced general body pain, headache and activities of daily living impaired. On 14th December 2019, the patient experienced fatigue. On 15th December 2019, the outcome of the general body pain, fatigue and activities of daily living impaired were recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the general body pain, fatigue, headache and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose if Shingrix in the right arm around 4 pm. The next day after vaccination, the patient had extreme body pain from head to toe and laid out on couch due to not being able to do normal activities. The following day, the patient experienced fatigue and next day the reporter stated that all symptoms were resolved than headache, which was resolved in approximately 1 to 2 more days.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: pain at injection site; joint pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old 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 11th September 2019, refer case US2019222769 ).   On 15th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain and joint pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the joint pain was unknown.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and continued to experience joint pain and pain at the injection site.The patient reported that she was going to physical therapy for the joint pain all over her body. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up. Furthermore, the patient reported that she was aware of people that had the injection and experienced pain at the injection site, but no further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Diffuse large B-cell lymphoma, Non-Hodgkin's lymphoma
Clinical narrative: Large B-cell non-Hodgkin lymphoma; Large B-cell non-Hodgkin lymphoma; This case was reported by a consumer and described the occurrence of diffuse large b-cell lymphoma in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (around the upper torso and were very painful) and nerve pain (several years ago).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced diffuse large b-cell lymphoma (serious criteria GSK medically significant and clinically significant/intervention required) and non-hodgkin's lymphoma (serious criteria GSK medically significant and clinically significant/intervention required). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the diffuse large b-cell lymphoma and non-hodgkin's lymphoma were unknown.   It was unknown if the reporter considered the diffuse large b-cell lymphoma and non-hodgkin's lymphoma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 80 years or 81 years. The patient received Shingrix vaccine, 3 years before the reporting date. From the last year (2018), the patient have been undergoing chemotherapy for Large B-cell non-Hodgkin Lymphoma and received last chemo at the end of May. The patient tolerated the chemo very well. The patient's daughter was concerned that, this chemotherapy might wiped out the vaccines ability to protect patient from shingles and thought that, the patient should get new Shingrix vaccine. The patient asked, whether this could create any issue if received Shingrix after chemotherapy. Also the patient was on a very limited income and asked for available discount program for Shingrix.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Vaccine given x's 2 Patient had URI at time Patient was aware of vaccine given and immunization form completed and signed by patient Patient mentioned vaccine had been given to him at work in October. Not documented through database or in patient's chart.
Age: 12.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Dizziness, Fall, Gait disturbance, Loss of consciousness
Clinical narrative: Patient (accompanied by mother) received 8 vaccines in the immunization clinic at 2:50pm. He reported mild dizziness within 3 minutes and put his head between his legs in the IZ exam room. After about 5 minutes he reported he felt better. He declined laying down on a yoga mat on the floor. I instructed him, with his mother, to sit in the waiting room for 10 more minutes before he left. The exam room was very warm and the waiting room would be cooler. He reported feeling okay when he stood up from the chair in the exam room. When we walked into the waiting room, he reported he felt dizzy. I held his arm to help him into a chair and he stumbled and then fell to the ground, slightly assisted by my arm. He did not strike his head or injure any part of his body. He appeared to lose consciousness for about 5-10 seconds and then awoke. I called for another nurse and instructed him to remain laying on the ground for 5 minutes. When he reported feeling no longer dizzy, I helped him into a chair where he sat for 15 minutes and drank juice. He left with his mother in her private vehicle after reporting no symptoms for 15 minutes.
Age: 58.0
Sex: M
Vaccine: MNQ
Symptoms: Blood lactic acid increased, Blood sodium decreased, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: 1 day after recieving vaccine, at emergency department pt arrives febrile, tachycardic, normotensive. Well appearing overall.  R shoulder vaccine site is erythematous, warm, tender, and indurated. Feel he is septic from R shoulder cellulitis, low concern for septic arthritis given full ROM and no pain with short arc ROM.
Age: 58.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site warmth, Pyrexia, Sepsis, Tachycardia
Clinical narrative: 1 day after recieving vaccine, at emergency department pt arrives febrile, tachycardic, normotensive. Well appearing overall.  R shoulder vaccine site is erythematous, warm, tender, and indurated. Feel he is septic from R shoulder cellulitis, low concern for septic arthritis given full ROM and no pain with short arc ROM.
Age: 58.0
Sex: M
Vaccine: MNQ
Symptoms: White blood cell count increased
Clinical narrative: 1 day after recieving vaccine, at emergency department pt arrives febrile, tachycardic, normotensive. Well appearing overall.  R shoulder vaccine site is erythematous, warm, tender, and indurated. Feel he is septic from R shoulder cellulitis, low concern for septic arthritis given full ROM and no pain with short arc ROM.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Injection site joint pain, Injection site pain, Middle insomnia, Sleep disorder
Clinical narrative: Left shoulder pain feels like muscle and joint pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Right upper arm pain since the flu shot (Nov 4, 2019) constant, sharp, when she sleeps it radiates down to the wrist and her whole  arm, no falls or injuries, no rashes.  9/10 pain. Occasionally radiating down her arm. Pt is also right handed. Right upper arm examination: tenderness localized along the lateral aspect between the deltoid muscle and the lateral/head of the triceps brachii. No erythema, edema, normal range of motion. compared to the left.
Sex: F
Vaccine: MMR, MMR
Symptoms: Antibody test negative, Product storage error
Clinical narrative: the patient had "titers drawn on anunspecified date which showed low titers for Mumps."; improperly stored MMR II; This spontaneous report has been received from a nurse, referring to a currently 44 years old female patient. The patient had no pertinent medical history, concomitant medication nor drug reactions or allergies.    On an unknown date (reported when the patient was a child), the patient was vaccinated with an unspecified measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, lot# and expiration date were unknown) intramuscularly for prophylaxis (reported as routine vaccination). On an unspecified date, the patient had  titers drawn which showed low for mumps. It was reported that the patient sought medical attention and the patient went to the physician office, then on 18-NOV-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S007813, expiration date 14-MAR-2021, strength was unknown) intramuscularly for prophylaxis (reported as routine vaccination). On 19-DEC-2019, the patient was vaccinated with a booster dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S007813, expiration date 14-MAR-2021, strength was unknown) intramuscularly for prophylaxis (reported as routine vaccination), following a temperature excursion. Properly stored sterile diluent (STERILE DILUENT) (lot# S016837, expiration date 01-FEB-2022) was used to reconstitute both the initial dose and the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of titers drawn which showed low for mumps was unknown, the causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the event was not reported, the causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the event was not related.  The vaccine was exposed to temperature excursion of above 9 degrees Celsius (17 C) for 71 hours. No previous temperature excursion. The call was due to a data logger. No product quality complaint presented.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick/ knocked down; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 4th December 2019, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter wanted to find out what was in Shingrix that was making people sick for days?  The reporter wanted to know if it had preservatives in it. The reporter asked pharmacist and pharmacist said that every once in a while people will be knocked down for a few days" after getting injection with Shingrix. This case was linked with the case US2019221810, reported by same reporter.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Product storage error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the PFS Pediarix vaccine was activated one day ago, which led to incorrect storage of drug. The reporter wanted to know if the vaccine can still be use a day after the activation.
Sex: U
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B surface antigen positive
Clinical narrative: Hep A IGM antibody was negative; Hep A IGM antibody was negative; This case was reported by a physician via call center representative and described the occurrence of hepatitis a antibody negative in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix, the 2nd dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, Twinrix and Twinrix, the patient experienced hepatitis a antibody negative and therapy non-responder. On an unknown date, the outcome of the hepatitis a antibody negative and therapy non-responder were unknown.   It was unknown if the reporter considered the hepatitis a antibody negative and therapy non-responder to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated there were 4 to 5 patients who received complete Twinrix series but no patient details were available. Their blood test for Hepatitis B (antibodies to Hepatitis B surface antigen) were positive but Hepatitis A IGM antibody was negative, which led to negative titer. The reporter also asked whether they did the wrong test for Hepatitis A or should they be testing IGG and not IGM.  The reporter consented to follow up.      Lab Comments: On an unknown date the patient performed blood test for Hep B and Hep A
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Blood test normal, Erythema, Fatigue
Clinical narrative: Initial swelling, redness, itching of left arm.  Pain in left arm that traveled to the right upper arm, across the back and neck.  I have reduced strength in both arms, have reduced energy and tire easily.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Metabolic function test normal, Muscular weakness, Neck pain, Peripheral swelling
Clinical narrative: Initial swelling, redness, itching of left arm.  Pain in left arm that traveled to the right upper arm, across the back and neck.  I have reduced strength in both arms, have reduced energy and tire easily.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Initial swelling, redness, itching of left arm.  Pain in left arm that traveled to the right upper arm, across the back and neck.  I have reduced strength in both arms, have reduced energy and tire easily.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pain, Screaming, Vomiting
Clinical narrative: Vaccine was in the morning and late afternoon he threw up twice bright yellow and screamed in pain for two days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: None known at this time
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Adverse Event: redness and swelling 4in width x 4in height injection site 2in from shoulder medial redness and swelling extending 2.25 in anterior lateral; 2in posterior lateral induration of dense tissue 2.5in medial Treatment: ibuprofen (12.5 ml of childrens) every 6-8 hours and benadryl every 6 hours (12.5ml of children's) ice pack to area 15 min 5-6 times a day monitor for more redness, swelling, pain, can't move arm, red streaks down arm, drainage from site, or fever (100.4 or greater)
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Impaired work ability, Injection site pain, Insomnia, Loss of personal independence in daily activities
Clinical narrative: I received the flu vaccine in my IT department. We have nurses that work in our department that administer the flu shot to employees who work in this off site location. The injection felt and hurt normally as it would with any shot. That night I felt very tired, sore, and the next day stayed home from work. By the end of the day Thursday 10.3 and into 10.4 I was unable to move my left arm without significant pain. I could not get dressed independently, could not lift things, open doors, or pick up a child. I could not sleep the night of 10.3. I went to occupational health on 10.4 at Hospital who deals with our employee occupational health issues. I was seen by an APRN. It was noted that the injection was not given in the correct location (too high). I was put on high dose prednisone. I subsequently followed up with my own PCP and was told the same and given the same regimen. After the prednisone was over the pain came back, so I went to see an orthopedic doctor. I have had an xray and an MRI now. I am still having pain in my left shoulder.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging, Pain, Product administered at inappropriate site, Weight bearing difficulty, X-ray
Clinical narrative: I received the flu vaccine in my IT department. We have nurses that work in our department that administer the flu shot to employees who work in this off site location. The injection felt and hurt normally as it would with any shot. That night I felt very tired, sore, and the next day stayed home from work. By the end of the day Thursday 10.3 and into 10.4 I was unable to move my left arm without significant pain. I could not get dressed independently, could not lift things, open doors, or pick up a child. I could not sleep the night of 10.3. I went to occupational health on 10.4 at Hospital who deals with our employee occupational health issues. I was seen by an APRN. It was noted that the injection was not given in the correct location (too high). I was put on high dose prednisone. I subsequently followed up with my own PCP and was told the same and given the same regimen. After the prednisone was over the pain came back, so I went to see an orthopedic doctor. I have had an xray and an MRI now. I am still having pain in my left shoulder.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt in with swelling, redness, and heat to right arm following her flu and Pneumococcal 23 vaccine in the right deltoid on 12/31.  Redness and swelling noted from shoulder to down her arm 22 cm and at the widest it was 10 cm about mid arm. Area is warm and painful to touch.  Dr in to see pt. Dr wrote a script for Prednisone 20 mg BID x 5 days for pt to bring into pharmacy.  Pt also encouraged to take  Benadryl and ice the affected area. Pt discharged in good condition.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Groin pain, Pain, Tenderness, Urine analysis
Clinical narrative: Patient developed left groin pain that radiated to his left hip- Testicles felt very tender- this happened the day after receiving the injection
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling pain in deltoid swelling in hand US to rule out DVT is negative
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Redness, swelling pain in deltoid swelling in hand US to rule out DVT is negative
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoacusis, Laboratory test, Lip swelling, Nausea
Clinical narrative: Patient was present to have flu vaccine.  Approximately 10 minutes after shot patient complained of headaches, being nauseous and having difficulty hearing out of right ear.  Immediately, , MD notified .  MD observed patient experiencing swollen lips.  Benadryl was given. MD informed mom to take patient to Hospital
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Muscle spasms, Musculoskeletal pain, Paraesthesia
Clinical narrative: On 12/19/19 pt contacted the office stating that she was having left upper arm pain 2 days after receiving the FLU vaccine in our office on 12/09/19,  then few days after the pain was radiating to left upper shoulder including shoulder blade, then few days later she started having severe left upper back spasms with bilateral legs tingling sensation on and off. Stated the pain was so severe that she asked her neighbor to take her to the closest ED for evaluation. ED referred her to a neurologist. Stated she was seen by a neurologist on 12/19/19 who told her that her symptoms were probably  a reaction to the FLU vaccine and to reporter it to the clinic where she received the vaccine.  Seqirus, INC was contacted to report vaccine reaction and find out if similar reactions had been reported by others but was told that they did not have that information available.
Age: 46.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Back pain, Paraesthesia
Clinical narrative: On 12/19/19 pt contacted the office stating that she was having left upper arm pain 2 days after receiving the FLU vaccine in our office on 12/09/19,  then few days after the pain was radiating to left upper shoulder including shoulder blade, then few days later she started having severe left upper back spasms with bilateral legs tingling sensation on and off. Stated the pain was so severe that she asked her neighbor to take her to the closest ED for evaluation. ED referred her to a neurologist. Stated she was seen by a neurologist on 12/19/19 who told her that her symptoms were probably  a reaction to the FLU vaccine and to reporter it to the clinic where she received the vaccine.  Seqirus, INC was contacted to report vaccine reaction and find out if similar reactions had been reported by others but was told that they did not have that information available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling face
Clinical narrative: Face redness & swelling
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Incorrect dose administered, Nausea
Clinical narrative: Redness; Headache; Nausea; 16 year old received second dose of PREVNAR 13; This is a spontaneous report from a contactable healthcare professional via Pfizer Sales Representative. A 16-year-old female patient received first dose of pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that after first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), the patient had redness, headache and nausea. The outcome of the events, redness, headache and nausea was recovered as the symptoms lasted for about 12 hours. After her second dose on an unspecified date, she only had about 1/2 the amount of redness on the arm and that was all. On an unspecified date, it was realized that the patient experienced inappropriate dose of vaccine received as the 16 year old patient received second dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).  Information on the batch number has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphocyte percentage decreased, Monocyte count increased, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Pain, redness and swelling on left arm Treated with IV Fluids and Antibiotics
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, White blood cell count increased
Clinical narrative: Pain, redness and swelling on left arm Treated with IV Fluids and Antibiotics
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Bedridden, Chills, Condition aggravated, Fatigue
Clinical narrative: Patient came to see me on 1/2/2020. She is not sure exactly what vaccine she was given, but was told it was preservative free.  Within three hours of administration the patient was bedridden with high fever, chills, shivering violently, severe fatigue, vomiting  headache,  very forgetful & spacey.  Exacerbated insomnia and anxiety.  Although she no longer had a fever or vomiting, all of her symptoms were continuous since the injection. She was given a homeopathic remedy by another physician which helped temporarily.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Insomnia, Memory impairment, Pyrexia
Clinical narrative: Patient came to see me on 1/2/2020. She is not sure exactly what vaccine she was given, but was told it was preservative free.  Within three hours of administration the patient was bedridden with high fever, chills, shivering violently, severe fatigue, vomiting  headache,  very forgetful & spacey.  Exacerbated insomnia and anxiety.  Although she no longer had a fever or vomiting, all of her symptoms were continuous since the injection. She was given a homeopathic remedy by another physician which helped temporarily.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient came to see me on 1/2/2020. She is not sure exactly what vaccine she was given, but was told it was preservative free.  Within three hours of administration the patient was bedridden with high fever, chills, shivering violently, severe fatigue, vomiting  headache,  very forgetful & spacey.  Exacerbated insomnia and anxiety.  Although she no longer had a fever or vomiting, all of her symptoms were continuous since the injection. She was given a homeopathic remedy by another physician which helped temporarily.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Irritability
Clinical narrative: "Red spot" in the area of one of her shots on her lateral right thigh that began the day after receiving the vaccines (10 days). She has not had fever or chills.  She is eating and drinking well, but is more irritable than usual.  She is less active than usual. She has been itching the injection site. 2.5 mL of Benadryl ordered every 6 hours as needed for the itching and the injection site reaction. Advised that mom give it to her until the rash on her right leg is less red and much smaller.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Scab
Clinical narrative: Allergic reaction over a year.  She has scabs on her arm and on her back.