chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Prothrombin time prolonged, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, White blood cell count increased
Clinical narrative: Patient received first Shingrix vaccine on 4/29/2020.  She awoke the next morning with cold sores -that were recurrent and worse than she is ever had.  Patient presented to clinic on 5/7/2020 as a cold sores were not getting any better with usual treatment of Abreva over-the-counter.  She had also presented with a under the right breast yeast infection during that same clinic visit.  Recently before this visit back at the end of April the patient had increased her Lexapro and we had added a low-dose 100 mg of Wellbutrin nightly -patient reports at the most recent visit that she was doing quite well on both his medication with no concern.  For the cold sore we had decided to go with a valacyclovir 2 g twice a day for 1 day.  For the yeast infection we agreed on ketoconazole.  Patient then called in on 5/8/2020 with concerns of fever, headache, nausea and overall feeling very rundown.  As her PCP I called her to find out in more detail her symptoms and sent her for COVID testing along with influenza and RSV testing.  When she went to go get evaluated at our COVID tent/trailer she was found to be hallucinating and disoriented.  She was then admitted to Hospital for further evaluation.  He became quite agitated and irritable along with paranoid.  Lumbar puncture was unsuccessful but she was admitted for possible management of herpes encephalitis and to exclude COVID-19.  Patient was given haloperidol, lorazepam, acyclovir, tracks own and vancomycin.  She was COVID negative along with influenza and RSV negative.  She had a CT scan of her head and abdomen.  Both showed no concerns for a potential infection as her WBC was 22.4 with a neutrophil percentage of 91.7 and absolute neutrophil count of 20.6.  She also had an elevated d-dimer of 582, elevated PT of 14.6, INR of 1.3, CRP of 118 and a pro BNP f 211.  She was admitted for overnight monitoring, IV fluids and IV acyclovir, vancomycin and ceftriaxone.  Patient left AMA the next morning.  I called the patient today, 5/12/2020, to see how she was doing.  Patient reports that she is otherwise feeling better and is not having any more concerning symptoms at this time.  She agreed to repeat labs today to check the above findings.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Blood test, Chills, Fatigue, Headache
Clinical narrative: Several hours after receiving injection, began to feel very fatigued. Within 1 hour after the fatigue, experienced severe body aches, chills, joint pain, fever (102f) and headache. Symptoms lasted until the next morning 6am.  Continue to have horrible headache and fatigue during day 2.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Several hours after receiving injection, began to feel very fatigued. Within 1 hour after the fatigue, experienced severe body aches, chills, joint pain, fever (102f) and headache. Symptoms lasted until the next morning 6am.  Continue to have horrible headache and fatigue during day 2.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Localised infection, Pain in extremity, Swelling
Clinical narrative: pt got sore arm, swelling,  felt warm, had to go to dr office to get antibiotic, dr says arm was infected
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: On Friday, May 8, 2020 at 12:42 pm patient received the PPSV23 vaccine. Around 5 pm that same day he complained that his arm hurt and mom noticed his upper arm was swollen, hard, red, warm, and painful to the touch. His swelling looked like a "Popeye arm" per mom. No fever. The next day, he still had all his symptoms but was getting better. The following day, the swelling and hardness did move down to his bicep close to the elbow. Mom marked the redness right away on Friday and the redness never did spread. Then on Monday, his symptoms are much better and almost gone.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Rash
Clinical narrative: Mother called this date 05/12/2020. Stating that her child has developed a rash on torso, now upward to  the rest the body. No to the following: SOB, Temp, Swelling, Redness to injection sites,  No to change in diet, No to change in laundry soap, No to any carpeting . Child did well after the injections with no complaints from child till 05/10/2020 per Mother. Advised mother to call the nearest E.R. for phone evaluation due to CoVid19. If advised to go to ER for evaluation of rash to body to do so as soon as possible. Mother states understanding.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: injection site soreness, muscle soreness; overall muscle soreness; slight fever (99.2)
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Insomnia
Clinical narrative: Headache, Joint pain, Muscle pain, Fatigue, tiredness, insomnia, little bit loss of appetite
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Headache, Joint pain, Muscle pain, Fatigue, tiredness, insomnia, little bit loss of appetite
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Strabismus
Clinical narrative: Patient went cross eyed an hour following these vaccinations and has been cross eyed since this date, November 14, 2019.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood bicarbonate normal, Blood culture negative, Blood sodium normal, Blood urine present, CSF cell count increased
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture negative, CSF glucose normal, CSF lymphocyte count normal, CSF neutrophil count increased, CSF protein increased
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF white blood cell count increased, Chest X-ray normal, Culture urine negative, Electroencephalogram normal, Eye movement disorder
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Foaming at mouth, Full blood count, Herpes simplex test negative, Influenza virus test negative, Metabolic function test
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Procalcitonin increased, Pyrexia, SARS-CoV-2 test negative, Seizure
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure like phenomena, Tardive dyskinesia, Tongue thrust, White blood cell count increased
Clinical narrative: A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1, UNK
Symptoms: Wrong product administered
Clinical narrative: I am reporting a vaccination error.  My wife took my 2 month old baby to doctor's office for his first round of routine vaccinations. Afterward, the nurse came into the room, and stated that she gave him the wrong vaccine! She gave him a vaccine that was meant for a 12 month olds body. UNACCEPTABLE! She stated that the vials were next to each other and similar in appearance and she must have grabbed the wrong one. She then proceeded to give him the correct vaccine when my wife told her NO, and asked to speak to the doctor. Not only was my newborn son injected with an incorrect vaccine and dosage, he is now behind on the vaccination schedule because they have to be given a certain time apart. Furthermore, my son will need to make an unnecessary separate appointment for the correct vaccination, thus exposing him to more things (Coronavirus). Completely unacceptable! Also, I am still monitoring my newborn for any potential side effects from this poor nurses error.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, IPV, RV1, UNK, UNK
Symptoms: Diet refusal, Screaming
Clinical narrative: Uncontrollable screaming and refusal to eat for two days
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: After receiving at age 12 Months MMR #1, Varicelle #1, PCV13 #4, Hep A #1, the next day she started with fever 101 F and a Maculopapular rash erythematous in trunk that spread to arms, legs and face and also had a big Macular erythematous Rash (about 4 cm diameter) where PCV13 vaccine was placed. Fever x 2 days. Rash is improving, resolving.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: RT deltoid immediate swelling w/redness, tender to the touch - Ice was applied, recommended to keep an eye.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood positive
Clinical narrative: Watery diarrhea started 4 days after vaccines. Stool is hene (+) but not grossly bloody
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to Patient. -Patient will Have re-administered
Sex: F
Vaccine: MMR
Symptoms: Antibody test positive, Mumps, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: her titers were negative for Rubella.; She developed the mumps.; This spontaneous report was received from a female consumer of 55-year-old referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unspecified date in September 1966, the patient was administered with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). Then, on an unspecified date in 1970, she was administered with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown); 1 dosage form, both administered for prophylaxis by subcutaneous route (concentrations, schedules, lot numbers, and expiration dates were not reported).   On an unspecified date in 1970, after being administered the 2nd dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), the patient developed mumps. In December 1999, the patient had a blood work performed, which reported positive titers. Then, on an unspecified date in 2020, (reported as "a few weeks ago") she had a blood work performed, which reported her titers were negative for Rubella (rubella antibody negative). The patient did not seek medical attention.  At the time of reporting, the patient was not recovered from mumps and rubella antibody negative. The relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; patient was inadvertently administered an expired dose of VARIVAX (Lot R011807 Exp 4/23/2020) on 5/1/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. The concomitant medication included sterile diluent which was not expired.  On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) one dosage form, lot number R011807 with an expiration date on 23-APR-2020 (strength, anatomical location of injection, vaccination scheme, and route of administration were not reported) for prophylaxis (expired product administered). No temperature excursion was reported for the vaccine, no additional adverse events nor quality complain involved.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Vaccination complication
Clinical narrative: Equivocal titer for rubella; had a previous unspecified reaction to the measles vaccine; This spontaneous report was received from a nurse concerning to a currently 18-year-old non-pregnant female patient. The patient's concurrent conditions included hereditary serositis and acquired asplenia (reported as aspenia). Drug reactions/allergies included unspecified reaction to measles virus vaccine live (unspecified), meningococcal B rfHbp vaccine (E. coli) (TRUMENBA) vaccine, and influenza virus vaccine (unspecified) (reported as flu vaccine). Concomitant medications were not provided.  On an unspecified date in 2003, she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage regimen, lot# and expiration date were not provided), administered subcutaneous. Indication was reported as "needed rubella booster for college".  On an unknown date, the patient went because she "needed a booster of rubeola vaccine (unknown) for an equivocal titer" (rubella antibody negative), and it was reported that she had an unspecified reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (vaccination complication) when she was vaccinated (on an unspecified date in 2003). The outcome of the events of vaccination complication and rubella antibody negative was not reported.        The causal relationship between the event of rubella antibody to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; the patient was inadvertently administered a expired dose of ROTATEQ; 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 reported.  On 11-MAY-2020, the medical assistant reported that the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot # R027159 with expiration date of 30-APR-2020, oral, frequency not reported) for prophylaxis. There was no temperature excursion. No additional adverse event (AE) information was reported.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose ofROTATEQ (Lot#R025732/Exp:3/25/2020) that was expired; This spontaneous report was received from a nurse prescriber referring to a 9 week old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 07-MAY-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R025732, expiration date: 25-MAR-2020 (strength, and dose number were not provided) for prophylaxis. No additional adverse event was reported.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Given at pharmacy
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Dyskinesia, Excessive eye blinking, Fatigue, Hypotonia
Clinical narrative: Received call from Health center at 20:28 regarding seizure-like activity. Discussed with mother who stated that patient seemed herself until early evening when she seemed fussy and clingy, not her usual temperament. Around 7:30 PM her mother was preparing a bath for her to soothe her when she noticed patient was staring off and not responding. She then started having full body jerking and stiffening which lasted no longer than 30 seconds. When her mother picked her up she seemed like "dead weight...limp." She initially was not responding to her mother calling her nickname. She eventually came out of it and then seemed fussy and tired afterward. She now is watching tv show and seems more tired than usual (bedtime around 9-9:30 PM) and very clingy. She seems like she is blinking often almost trying to stay awake. She occasionally pokes at her eyes which is a new behavior. She has not received any medicine. She had her well visit today which prompted catch-up vaccines including MMR, varicella, Dtap/Hib/IPV and Prevnar. She has not had reaction to vaccines in the past Temperature never measured greater than 99
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Irritability, Musculoskeletal stiffness, Seizure like phenomena, Staring, Unresponsive to stimuli
Clinical narrative: Received call from Health center at 20:28 regarding seizure-like activity. Discussed with mother who stated that patient seemed herself until early evening when she seemed fussy and clingy, not her usual temperament. Around 7:30 PM her mother was preparing a bath for her to soothe her when she noticed patient was staring off and not responding. She then started having full body jerking and stiffening which lasted no longer than 30 seconds. When her mother picked her up she seemed like "dead weight...limp." She initially was not responding to her mother calling her nickname. She eventually came out of it and then seemed fussy and tired afterward. She now is watching tv show and seems more tired than usual (bedtime around 9-9:30 PM) and very clingy. She seems like she is blinking often almost trying to stay awake. She occasionally pokes at her eyes which is a new behavior. She has not received any medicine. She had her well visit today which prompted catch-up vaccines including MMR, varicella, Dtap/Hib/IPV and Prevnar. She has not had reaction to vaccines in the past Temperature never measured greater than 99
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT IS COMPLAINING OF ARM PAIN 8 MONTHS AFTER FIRST INJECTION.  SHE SAID SHE HAS TROUBLE RAISING HER ARM ABOVE HER SHOULDER.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: LEFT SHOULDER BURNS AND ACHES LIKE NERVE WAS DAMAGED.  NO TREATMENT.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Off label use
Clinical narrative: off label use; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to an 8-year-old female patient. No information regarding the patient's concurrent conditions or concomitant medications was provided. On an unknown date, the patient presented to the emergency department (ED) with intermittent vaginal bleeding for approximately 1 month. Initially, the patient reported dysuria, which resolved with a course of antibiotics (unspecified) for a presumed urinary tract infection. On presentation to the ED, her vaginal lesion was visualized at the introitus, extending up the right vaginal wall and towards the urethra as a 1-2 cm red/purplish polypoid and friable mass. The patient was taken for an exam under anesthesia with vaginoscopy (no result was provided). On an unknown date, biopsy of the vaginal mass revealed a squamous papilloma with koilocytic atypia. There was no evidence of malignancy. The atypia present, although significant, was similar to that seen in human papilloma virus (HPV) infections. Tissue was sent for HPV in situ hybridization testing which indicated positivity for HPV types 6 and/or 11. On an unknown date, approximately 1 month after the procedure, the bleeding had decreased to intermittent spotting, but there was minimal change observed in the appearance of the vaginal lesion. It was recommended for the patient to have early administration of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine.  On an unknown date, the patient was vaccinated with a dose of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, frequency, route of administration, lot# and expiration date were not reported) for squamous papilloma and start applying Imiquimod cream.  Literature Report:.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Therapeutic response unexpected
Clinical narrative: neuralgia has greatly improved; tiny bit of itching due to her neuralgia; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included neuralgia (has had shingles in the past which resulted in her suffering from neuralgia). Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced unexpected therapeutic effect and pruritus. On an unknown date, the outcome of the unexpected therapeutic effect and pruritus were unknown.   It was unknown if the reporter considered the unexpected therapeutic effect and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient stated after getting her first dose of Shingrix in January of this year, her neuralgia had greatly improved.  The patient stated that on occasion, she gets a tiny bit of itching due to her neuralgia and she might take Lyrica once every 3 weeks or every month at 50 mg for it.  The patient also mentioned that she received the pneumonia vaccine on the same day of Shingrix but in the right arm. The patient did not want to share her healthcare provider's information at this time but did consent to having the form mailed to her, the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: Pain in the injection site; difficulty to sleep due to that pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and difficulty sleeping. On an unknown date, the outcome of the injection site pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but the patient was over 65 years old. The reporter did not provide initials, date of birth of the patient nor lot number and expiration date of the vaccine administered. It was reported that the patient received the first dose of Shingrix and started to experience pain in the injection site and difficulty to sleep due to that pain.  The reporter did not consent to follow-up.  The reporter mentioned that the patient received the vaccine sometime during the 2 last weeks of March 2020 in a pharmacy.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: & syncope
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Headache, Skin lesion, Tenderness
Clinical narrative: left arm about 10 cm round erythematous lesion, tender to pressure. Pt c/o headaches.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: & weakness
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Extreme shivers, Headache, fever (100.4), body ache and soreness at vaccine site
Sex: F
Vaccine: HPV9
Symptoms: Abortion, Maternal exposure before pregnancy
Clinical narrative: is patient pregnant: no; patient became pregnant; This spontaneous report was received from a pharmacist and refers to a 27-year-old female patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  On an unspecified date, the patient was administered with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not provided).  On another unspecified date, after receiving the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became pregnant. The patient was not pregnant for either dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). Aside from pregnancy, no symptoms were reported.  On an unknown date, the patient pregnancy end.  The outcome of the events was unknown. The causality assessment was not provided.  Upon internal review the event of abortion was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles (herpes zoster). On an unknown date, pt was hospitalized due to the event. As a direct and proximate result of pt used of the zoster vaccine live (ZOSTAVAX) vaccine, pt 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 herpes zoster was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 48 YO was given the 1st dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2020, the patient received the 1st dose of Shingrix. On 6th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: The patient received Shingrix at the age of 48 year, which led to inappropriate age at vaccine administration. No additional details reported.
Age: 71.0
Sex: F
Vaccine: RAB
Symptoms: Muscle contractions involuntary
Clinical narrative: Muscle fasciculation in left arm; This case was reported by a physician via call center representative and described the occurrence of fasciculation in a 71-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite (rabid bat). Concomitant products included Rabies NVS (RabAvert).   On 3rd May 2020, the patient received the 2nd dose of RabAvert. On an unknown date, less than a week after receiving RabAvert, the patient experienced fasciculation. On an unknown date, the outcome of the fasciculation was unknown.   It was unknown if the reporter considered the fasciculation to be related to RabAvert.  Additional details were reported as follows: The patient just completed 2 doses on day 0 and day 3 after post-exposure to rabid bat on 30th April 2020 and 3rd May 2020.  The patient experienced muscle fasciculation in left arm.  Exposure could have been a week before starting treatment. The reporter did not give consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Plasma cell myeloma, Radiotherapy
Clinical narrative: received the first dose of Shingrix. After this dose, the patient received radiotherapy for the treatment of multiple myeloma; This case was reported by a pharmacist via call center representative and described the occurrence of multiple myeloma in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced multiple myeloma (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Radiotherapy). On an unknown date, the outcome of the multiple myeloma was unknown.   It was unknown if the reporter considered the multiple myeloma to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. A pharmacist reported that five to six months before this report, a patient received the first dose of Shingrix.  After this dose, the patient received radiotherapy for the treatment of multiple myeloma.  The pharmacist does not know if the diagnosis of multiple myeloma was before or after dose one of Shingrix. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a health care provider, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a physician for shingles (herpes zoster). On an unknown date, pt was hospitalized due to the event. As a direct and proximate result of pt used of the zoster vaccine live (ZOSTAVAX) vaccine, pt 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 herpes zoster was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Ipol was administered to a patient/ No AE; Initial information was received on 07-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six years old male patient who, on 06-May-2020 was administered with 0.5 mL dose of expired vaccine IPV (VERO) (lot P1A25 and expiry date 02-May-2020)  via subcutaneous route in the left arm for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); HEPATITIS A VACCINE (HEPATITIS A VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) (flu vaccine) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Glossodynia, Hyperhidrosis, Oropharyngeal pain, Rash erythematous, Rash pruritic
Clinical narrative: Evening of shot (5/9) tongue bled after brushing and was sore with a red stripe in the middle, throat also felt sore. Lasted about 2 days. 2 days after shot started developing a rash which progressively spread to cover entire stomach, breasts, and back. Rash is small red bumps that itch mildly. Rash is still here after 2 days.  Since shot I have also woken up drenched in sweat every night- but I?m not sure if this is related to the vaccine or post-part I?m pregnancy hormones.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Tongue erythema, Tongue haemorrhage
Clinical narrative: Evening of shot (5/9) tongue bled after brushing and was sore with a red stripe in the middle, throat also felt sore. Lasted about 2 days. 2 days after shot started developing a rash which progressively spread to cover entire stomach, breasts, and back. Rash is small red bumps that itch mildly. Rash is still here after 2 days.  Since shot I have also woken up drenched in sweat every night- but I?m not sure if this is related to the vaccine or post-part I?m pregnancy hormones.
Age: 0.33
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given the Varicella vaccine at 4 months and 3 weeks of age. The patients mother didn't list any adverse reactions while on the phone 5/7/2020.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: The symptoms  came on quickly at 12:30 a.m.  5/13/20.  I had chills/shivering, 100 degree temperature by mouth,  severe headache, dizziness, nausea, achy joints and muscles, tired, difficulty concentrating.    I still had these symptoms until about 2:00 p.m. 5/13/20  and then started feeling better.  It is now 5:00 p.m.  I have a mild headache, a little dizzy and still have difficulty concentrating.  I've taken Xtra strength Tylenol and Advil for headache and body aches.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: The symptoms  came on quickly at 12:30 a.m.  5/13/20.  I had chills/shivering, 100 degree temperature by mouth,  severe headache, dizziness, nausea, achy joints and muscles, tired, difficulty concentrating.    I still had these symptoms until about 2:00 p.m. 5/13/20  and then started feeling better.  It is now 5:00 p.m.  I have a mild headache, a little dizzy and still have difficulty concentrating.  I've taken Xtra strength Tylenol and Advil for headache and body aches.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Tremor
Clinical narrative: The evening of the vaccination the patient had a sore left upper arm.  The patient experienced shaking and chills that lasted all night long.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Heart rate irregular, Musculoskeletal stiffness, Nail infection
Clinical narrative: Stiff neck on side of vaccine, small irregular heart beat. Due Date 7/28/20 Also had a tetanus shot around End of November, Beginning of December for what they thought was a nail infection and knew I was pregnant at a clinic which I informed my Doctor. We proceeded with maybe what could been second dose yesterday of same shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Ear pain, Fatigue, Headache
Clinical narrative: 14 hours after shot severe chills, shaking, mild stomach pain, mild ear ringing/pain, severe headache. Fatigue for 48 hours post injection with mild headache. Severe arm pain at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Tinnitus, Tremor
Clinical narrative: 14 hours after shot severe chills, shaking, mild stomach pain, mild ear ringing/pain, severe headache. Fatigue for 48 hours post injection with mild headache. Severe arm pain at injection site.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Attention deficit hyperactivity disorder, Encephalitis, Injection site discolouration, Injection site erythema, Injection site inflammation
Clinical narrative: Child was given the shot on 7/30. Spot of injection became red and inflamed. Became progressively worse. By 8/1 his whole thigh was red and purple, hot, and swollen. Was told by my pediatrician to draw a line around the area and if the swelling and redness went outside the line to go to the ER. We took my son to the ER, he was given Benadryl and Clindamycin to counter the reaction. He was diagnoses with a vaccine reaction in the ER.  Took two days for the swelling to subside. Shortly after this shot my child began having sleep issues, hyperactivity issues, and has since been diagnoses with sensory processing disorder, ADHD, and encephalitis like reactions.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Psychomotor hyperactivity, Sensory processing disorder, Sleep disorder
Clinical narrative: Child was given the shot on 7/30. Spot of injection became red and inflamed. Became progressively worse. By 8/1 his whole thigh was red and purple, hot, and swollen. Was told by my pediatrician to draw a line around the area and if the swelling and redness went outside the line to go to the ER. We took my son to the ER, he was given Benadryl and Clindamycin to counter the reaction. He was diagnoses with a vaccine reaction in the ER.  Took two days for the swelling to subside. Shortly after this shot my child began having sleep issues, hyperactivity issues, and has since been diagnoses with sensory processing disorder, ADHD, and encephalitis like reactions.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: Child was given the shot on 7/30. Spot of injection became red and inflamed. Became progressively worse. By 8/1 his whole thigh was red and purple, hot, and swollen. Was told by my pediatrician to draw a line around the area and if the swelling and redness went outside the line to go to the ER. We took my son to the ER, he was given Benadryl and Clindamycin to counter the reaction. He was diagnoses with a vaccine reaction in the ER.  Took two days for the swelling to subside. Shortly after this shot my child began having sleep issues, hyperactivity issues, and has since been diagnoses with sensory processing disorder, ADHD, and encephalitis like reactions.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: patient says that after the receiving the flu shot her left arm continues have a dull pain and is still not going away
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Blisters & rashes on hands & foot the night after getting the SHINGRIX vaccine. Which got worse after one week.
Age: 38.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 38-year old-female came into the clinic today with concern that the injection site of the tetanus that was given to her yesterday had redness and itching around the area. Denies any history of allergies to Tdap vaccine. Denies any shortness of breath or any generalized pruritus. Patient also here to review her lab results.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: could not move her arm; difficulty slepp; very bad sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in 2019 at her doctor's office and her arm was very sore and she could not move her arm and it was so bad that she could not sleep for 1 day.  Sore arm persisted for 1 week then resolved.   The reporter did not consent to follow up. For tolerances for 2nd dose, refer case US2020AMR077787, reported by same reporter for the same patient.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Itching around injection site, rash around injection site, fever, chills, injection site soreness,
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose ofMMRII on 4/3/2020.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient pertinent medical history and drug reactions or allergies was provided.   On 03-APR-2020, the patient was administered an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (lot#S006048 with expiration date: 27-FEB-2021;  dose, frequency, strength and route of administration were not provided) for prophylaxis. The sterile diluent was properly stored. No additional adverse event (AE) information provided.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion under 47.3 degrees fahrenheit (F) for 14 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: that had been improperly stored; No additional adverse event; This spontaneous report was received from a medical assistant, referring to a male patient of unknown age.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 03-MAR-2020, the patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (route of administration, vaccination scheme and anatomical site of vaccination, were not reported); lot number S006050, expiration date 12-DEC-2020, as prophylaxis.  The administered dose of the vaccine experienced a temperature excursion 50.7 degrees Fahrenheit (F) for 25 minutes, as recorded by a data logger. Previous temperature excursions was reported as no, however previous dates temperatures and time intervals were provided. There was no adverse effect reported.