chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Patient had no AE to the 1st Shingrix.  Patient AE started 2 hours after injection.  Dry heaves, diarrhea, hands wouldn't stop shaking, body aches all over, excessive sneezing, could hardly walk. Patient referred to Dr. Advised to take Tylenol. Patient slept. Patient feels a little better each day except joints hurt.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: He was found unresponsive 2 days later in pack-and -play. UNK if there were other symptoms.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: GENERALIZED RASH 3 days after DTAP vaccine given,
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Myalgia, Neuralgia, Pain
Clinical narrative: The pain, start, same day of vaccination, during night time, start on my LA, at the area of vaccine (Deltoide), Intermittently, I did not give attention because I thought was normal side eff. for the vaccine. Over time, the "pain" has been more and more frequent and runs through my forearm grabbing the path of the muscle and nerve, cross and end in the elbow. Not constant, but start 1/10 and now 5/10 (scale pain) and sometimes waking me up early in the morning and when I am try to move. My (LA) the pain is there, with the course. of the day. goes and comes.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: The pain, start, same day of vaccination, during night time, start on my LA, at the area of vaccine (Deltoide), Intermittently, I did not give attention because I thought was normal side eff. for the vaccine. Over time, the "pain" has been more and more frequent and runs through my forearm grabbing the path of the muscle and nerve, cross and end in the elbow. Not constant, but start 1/10 and now 5/10 (scale pain) and sometimes waking me up early in the morning and when I am try to move. My (LA) the pain is there, with the course. of the day. goes and comes.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Low grade fever, muscle aches, chills, nausea, swelling right deltoid area  Started within a few hours after administration of vaccines. Symptoms resolved by 11/9/2020.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: Patient reports light-headedness, fatigue, chills
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: CSF shunt operation, Child abuse, Retinal haemorrhage, Subdural haematoma, Subdural haematoma evacuation
Clinical narrative: Subdural hematoma Retinal Hemorrhage  required surgical evacuation , and in October 2020 a  ventriculoventricular shunt  Evaluation for non-accidental trauma, child services involved
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Blood culture, CSF glucose decreased, CSF neutrophil count positive, CSF protein increased
Clinical narrative: Event: Lethargy, fever, decreased urine output beginning a few hours after vaccination. Lumbar puncture and blood cultures revealing strep pneumoniae bacteremia and meningitis. Head CT revealing mastoiditis.  Treatment:   penicillin G IV total 14 days Outcome: Septicemia and meningitis resolved. However, residual mobility and balance issues.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: CSF red blood cell count positive, CSF white blood cell count positive, Computerised tomogram head abnormal, Gram stain positive, Lethargy
Clinical narrative: Event: Lethargy, fever, decreased urine output beginning a few hours after vaccination. Lumbar puncture and blood cultures revealing strep pneumoniae bacteremia and meningitis. Head CT revealing mastoiditis.  Treatment:   penicillin G IV total 14 days Outcome: Septicemia and meningitis resolved. However, residual mobility and balance issues.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture abnormal, Mastoiditis, Meningitis pneumococcal, Mobility decreased, Pyrexia
Clinical narrative: Event: Lethargy, fever, decreased urine output beginning a few hours after vaccination. Lumbar puncture and blood cultures revealing strep pneumoniae bacteremia and meningitis. Head CT revealing mastoiditis.  Treatment:   penicillin G IV total 14 days Outcome: Septicemia and meningitis resolved. However, residual mobility and balance issues.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Streptococcal bacteraemia, Streptococcus test positive, Urine output decreased
Clinical narrative: Event: Lethargy, fever, decreased urine output beginning a few hours after vaccination. Lumbar puncture and blood cultures revealing strep pneumoniae bacteremia and meningitis. Head CT revealing mastoiditis.  Treatment:   penicillin G IV total 14 days Outcome: Septicemia and meningitis resolved. However, residual mobility and balance issues.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Full body rash with hives
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Face oedema, Ultrasound scan
Clinical narrative: edema over right eyebrow and along forehead, per caregiver's history.  Seen in emergency department given ventriculoperitoneal shunt, neurosurgery consulted, cranial ultrasound done, no neurosurgical issues found, discharged to home, swelling improved.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Chest pain, Erythema, Pain in extremity, Swelling
Clinical narrative: Patient reports redness, swelling, and pain in arm and upper chest
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient called Clinic Pharmacy  at 12/05/20 around 10AM , reported a spike in fever at 4.00PM same day vaccine received. Area of injection tender, swollen red and warm to touch. Fever lasted for one day all other symptoms continued  present up to day of call in to pharmacy (4days ) 12/ 05/2020. Patient was advised to go the ER or hospital if no improvement or symptoms worsen. 12/05/2020 patient reported symptoms improving and not worsening than previous day 12/04/2020.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Approximately four hours after vaccination patient experienced quite a bit of pain, some swelling, and a temperature around 100 degrees.  I recommended alternating Aleve 220 mg every 12 hours, Acetaminophen 500mg every eight hours, and Benadryl 50mg every six hours as need to control reaction.  Thirty-six hours after vaccination redness from about 4 inches below the right shoulder extending to two inches above the elbow.  We are now six days post vaccination and symptoms resolving with no expected additional complications expected.
Age: 31.0
Sex: M
Vaccine: FLUA4
Symptoms: Chest discomfort, Nasal congestion, Oropharyngeal discomfort, Sneezing
Clinical narrative: Starting the day of vaccination, the patient started experiencing nasal congestion, frequent sneezing, throat and chest discomfort. He did not have any shortness of breath or difficulty breathing. He treated with Benadryl and Zyrtec and symptoms resolved in 24 hours. At clinic visit 3 days later, he is only experiencing mild throat discomfort with no associated SOB.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Culture throat, Irritability, Rash, SARS-CoV-2 test
Clinical narrative: pt on 12/2 received the above vaccines, 12/9 had temperature of 101-104. 12/10 had temp of 101.4 and started with rash on face and back and abdomen. cranky
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: pt on 12/2 received the above vaccines, 12/9 had temperature of 101-104. 12/10 had temp of 101.4 and started with rash on face and back and abdomen. cranky
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient recievd flu vaccine at MD office and Shingrix vaccine at pharmacy within 2 days apart. Pt experienced redness and mild swelling at injection site
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; some "temperature problems" that the vaccine underwent; This spontaneous report was received from a consumer and physician's office manager, referring to a  patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 10-SEP-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, lot # S036495 expiring on 13-SEP-2021, for prophylaxis (exact dose, route and site of administration were not reported).   The reporter stated they received a message from their physician that the patient and her husband needed to be revaccinated for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), due to some temperature problems" that the vaccine underwent. The caller and her spouse, would have an appointment on 11-NOV-2020, to receive another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine.  The office manager confirmed no adverse event occured. This is one of two reports received from the same reporter (cross-referenced with US-009507513-2011USA008179). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA008179:
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE; Vaqta was reported to have been administered post temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 m, lot # T013546 confirmed to be a valid lot #, expiration date 28-OCT-2021 for prophylaxis (strength, dose #, route of administration and anatomical location were not provided). The temperature excursion was as follows: 1.1 Celsius degree for 1 hour 23 minutes and 1.4 Celsius degrees for 30 minutes. There were no previous excursions reported. The digital data logger was not involved. No additional adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Musculoskeletal stiffness, Pain
Clinical narrative: Second in the Shingrix series. Individual experienced about 24-48 hours later; body was stiff, achy. Achiness was persistent till 12/7/2020.  Ongoing temperature, treating with Tylenol as-needed.   Individual had flu shot approximately early 10/2020
Age: 34.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Arthralgia, Fatigue, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling/firmness, increase in temperature at site of injection, low-grade fever, sore/achy joints, and fatigue.
Age: 34.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Pain, swelling/firmness, increase in temperature at site of injection, low-grade fever, sore/achy joints, and fatigue.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: B precursor type acute leukaemia, Bone marrow transplant, Death, Lymphocyte adoptive therapy
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pyrexia
Clinical narrative: Fever, shivers, body aches, and headache started around midnight, about 16 hours after injection and gone within 24 hours.  Also had redness and swelling after injection, worsened after 24 hours and still present at 48 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Fever, shivers, body aches, and headache started around midnight, about 16 hours after injection and gone within 24 hours.  Also had redness and swelling after injection, worsened after 24 hours and still present at 48 hours.
Age: 0.08
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Headache, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: 11/7/2020  after vaccine patient experience some pain in the arm with a slight headache about 4pm.  At 8:30 pm caller went to bed and callers husband  found caller to be confused with fever 107. Callers husband called ambulance and caller was taken hospital. O2 stats were 40 and blood sugar was 50.Caller stayed in hospital for 48 hours and was released on Tuesday.
Age: 0.08
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Nausea
Clinical narrative: 11/7/2020  after vaccine patient experience some pain in the arm with a slight headache about 4pm.  At 8:30 pm caller went to bed and callers husband  found caller to be confused with fever 107. Callers husband called ambulance and caller was taken hospital. O2 stats were 40 and blood sugar was 50.Caller stayed in hospital for 48 hours and was released on Tuesday.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Headache, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: PATIENT BECAME SHORT OF BREATH, NAUSEAUTED, TIRED, AND WENT TO BED BUT THEN WOKE IN THE ER.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Nausea
Clinical narrative: PATIENT BECAME SHORT OF BREATH, NAUSEAUTED, TIRED, AND WENT TO BED BUT THEN WOKE IN THE ER.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Blood test, Burning sensation, Chills
Clinical narrative: Patient experienced tingling and burning in both arms and hands on 11/24/2020.  Patient weak in both arms and hands,  crepitus in both arms. Went to ER for shoulder, thought popped out of socket in the following days. Pain level 9/10.  Tear on rotator cuff. Patient feels that this was in relation to his vaccination. Patient pushed shoulder back into socket, visited ER.  Surgeon referred Patient to  Primary doctor to run blood work.  Quivering still ongoing in both arms and hands;  'hard to make a fist'.  Ongoing symptoms; muscles tight on left and right side; 'Feels like someone pressing right down on the bone' in both arms. Waiting for lab results from PCP.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Crepitations, Muscle tightness, Rotator cuff syndrome
Clinical narrative: Patient experienced tingling and burning in both arms and hands on 11/24/2020.  Patient weak in both arms and hands,  crepitus in both arms. Went to ER for shoulder, thought popped out of socket in the following days. Pain level 9/10.  Tear on rotator cuff. Patient feels that this was in relation to his vaccination. Patient pushed shoulder back into socket, visited ER.  Surgeon referred Patient to  Primary doctor to run blood work.  Quivering still ongoing in both arms and hands;  'hard to make a fist'.  Ongoing symptoms; muscles tight on left and right side; 'Feels like someone pressing right down on the bone' in both arms. Waiting for lab results from PCP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: severe joint pain lasting about 12 hours, short-lasting chills and shaking, low-grade fever, nausea, headache, muscle ache, fatigue
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: severe joint pain lasting about 12 hours, short-lasting chills and shaking, low-grade fever, nausea, headache, muscle ache, fatigue
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor, Seizure, Syncope
Clinical narrative: pale; diaphoretic; Seizure like arm movements for 3-5 seconds after. Opened eyes right after seizure like movement.; Seizure like arm movements for 3-5 seconds after. Opened eyes right after seizure like movement.; Became dizzy; fainted; This initial information has been received on request by the Company from the FDA under the Act (Health Authority # 6230533) on 25-SEP-2020, concerning a 17-year-old female patient. Concomitant therapy included ethinyl estradiol (+) norgestimate. Information about medical history and concurrent conditions was not provided.    On 20-SEP-2019 at 09:55, 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) (lot # R028651, expiration date not reported, upon internal validation established as 27-JUL-2021, intramuscularly in the left arm; strength and dose were not reported) for prophylaxis.    On the same day at 09:58, the patient became dizzy, pale, diaphoretic and fainted within minutes of receiving injection. The patient experienced seizure like arm movements for 3-5 seconds after, opened eyes right after seizure like movement. The patient placed head between knees for 5 minutes, drank 2 glasses apple juice and ate crackers, then placed on stretcher to lie flat for 10 minutes. The patient gradually and incrementally raised hob to sitting position. The patient remained without further dizziness, vital signs (VS) remained stable throughout and she didn't eat breakfast. The outcome of the events was recovered. The causality assessment was not reported.  Follow up information was received on 07-DEC-2020 via an inbound call from a person of the general pediatrics. The reporter stated that a seizure convulsion letter was received addressed to a physician no longer at the practice and she could not identify the patient. After reviewing the case, the reporter stated that without additional patient identifiers and the physician information, the event could not be identified. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028651; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about September 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about 2017, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as after received zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was saw and treated by health care provided and was still under their care. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of the patient condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffered, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate resulted, the patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia were not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles and post-herpetic neuralgia. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited  to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event s was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumococcal Polysaccharide recieved on 23-SEP-2013 and Pneumococcal Conjugate received on 05-NOV-2015; No adverse event; This spontaneous report was received from a 69-year-old male patient, concerning to himself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 23-SEP-2013 the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 05-NOV-2015 another dose of  pneumococcal conj vaccine (unspecified) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1905USA009910:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Taking a flu shot knocks patient down for three weeks, haven't had the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer(patient) via social media on 29-Oct-2020.  This case is linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306276, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involves a patient of unknown demographics who taking a flu shot knocks patient down for three weeks, haven't had the flu (Influenza), while he/she received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect the patient taking a flu shot knocks patient down for three weeks, haven't had the flu (Influenza).  No laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient got Gillian Barre and about died; Initial information regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional (patient's daughter in law) via social media on 07-Dec-2020.  This case involves a female patient of unknown age who got Gillian Barre (Guillain-Barre syndrome), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) the patient got Gillian Barre (Guillain-Barre syndrome) following administration of INFLUENZA VACCINE. The event Guillain-Barre syndrome was considered medically significant. Reporter stated that patient was about to die.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for Guillain-Barre syndrome.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who was presented with Guillain-Barre syndrome after vaccination with non-company suspect Influenza Vaccine. The time to onset was uknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Moreover, one vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed
Sex: F
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case is linked to case 2020SA354103 (same reporter).  This case involve female patient (age not reported) who experienced Guillain-Barre Syndrome, while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre Syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death (Patient was buried on 06-Dec-2020).  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  It is unknown if an autopsy was done.   The causes of death was reported as Guillain-Barre Syndrome.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a female patient (age not reported) who died due to Guillain-Barre Syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Guillain-Barre syndrome
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (patient).  This case involves a patient of unknown demographic who experienced pneumonia, after the patient received INFLUENZA VACCINE.  Medical history, concomitant medications, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was stated that the patient never took another shot.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient outcome was Unknown for pneumonia.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient who experienced pneumonia, while he/she received vaccine INFLUENZA VACCINE. Time to onset is unknown. However, additional information on patients medical condition at the time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient left the exam room and proceeded to faint in the lobby, falling and hitting her head
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort
Clinical narrative: received vaccine in left deltoind. Initially no discomfort, but discomfort began and worsened into the evening hours
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Patient referred to ER on 11/27/20 due to lower extremity weakness since 11/20/20. Released with diagnosis of Guillain Barre Syndrome.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis, Acute flaccid myelitis, Encephalomyelitis, Magnetic resonance imaging brain abnormal, Myelitis transverse
Clinical narrative: acute flaccid myelitis, transverse myelitis or acute demyelinating encephalomyelitis
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Scan with contrast abnormal, White matter lesion
Clinical narrative: acute flaccid myelitis, transverse myelitis or acute demyelinating encephalomyelitis
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: patient complaining site of injection is still sore after administation
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Brain natriuretic peptide normal, Dyspnoea, Ocular hyperaemia, Periorbital swelling, Peripheral swelling
Clinical narrative: MBC # 4928142058 Redness and puffiness around the eyes, top and bottom. Spread all over extremities. Breathing; SOB, wheezing.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication, Wheezing
Clinical narrative: MBC # 4928142058 Redness and puffiness around the eyes, top and bottom. Spread all over extremities. Breathing; SOB, wheezing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: Sore arm as usual, but with the second vaccine I?m also experiencing  shivering. And I?m cold even though I?m dressed warmly in a warm house.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Depressed level of consciousness, Fatigue, Hypopnoea
Clinical narrative: Patient's husband reported wife's reaction as follows: Next day, patient was so weak that she could not get out of bed and needed to be carried out of the bath tub. Also experienced shallow breathing, inalertness, and severe fatigue for 3 days after immunization administration. No swelling, fever, or infection symptoms reported.
Age: 58.0
Sex: M
Vaccine: FLUA3
Symptoms: Ear discomfort, Headache, Sleep disorder
Clinical narrative: Patient explained he began experiencing headaches where he is unable to sleep and his ears keep popping.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chills, Dizziness, Dysphonia, Headache
Clinical narrative: Patient reported having a fever of 101.7 degrees with chills, abdominal cramps, vomiting, blurred vision, dizziness, laryngitis/hoarseness of voice, and headache. She described being awake intermittently throughout the night with these symptoms which continued into the next morning. She was seen at urgent care facility (UC) late that afternoon (on 11/12/20) for these symptoms and also to be tested for COVID-19 because of her fever. Rapid COVID antigen test was negative. Her fever resolved earlier that day & temperature measured 97.5 at UC. She reports UC told her to take Benedryl, which she did that evening upon reaching home. She reports feeling better a few hours after one dose of Benedryl. The following morning, 11/13/20, she reports feeling completely better with complete resolution of symptoms.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Laryngitis, Pyrexia, SARS-CoV-2 test negative, Sleep disorder, Vision blurred
Clinical narrative: Patient reported having a fever of 101.7 degrees with chills, abdominal cramps, vomiting, blurred vision, dizziness, laryngitis/hoarseness of voice, and headache. She described being awake intermittently throughout the night with these symptoms which continued into the next morning. She was seen at urgent care facility (UC) late that afternoon (on 11/12/20) for these symptoms and also to be tested for COVID-19 because of her fever. Rapid COVID antigen test was negative. Her fever resolved earlier that day & temperature measured 97.5 at UC. She reports UC told her to take Benedryl, which she did that evening upon reaching home. She reports feeling better a few hours after one dose of Benedryl. The following morning, 11/13/20, she reports feeling completely better with complete resolution of symptoms.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Patient reported having a fever of 101.7 degrees with chills, abdominal cramps, vomiting, blurred vision, dizziness, laryngitis/hoarseness of voice, and headache. She described being awake intermittently throughout the night with these symptoms which continued into the next morning. She was seen at urgent care facility (UC) late that afternoon (on 11/12/20) for these symptoms and also to be tested for COVID-19 because of her fever. Rapid COVID antigen test was negative. Her fever resolved earlier that day & temperature measured 97.5 at UC. She reports UC told her to take Benedryl, which she did that evening upon reaching home. She reports feeling better a few hours after one dose of Benedryl. The following morning, 11/13/20, she reports feeling completely better with complete resolution of symptoms.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient contacted the office on 10/08/2020 and stated that she received the pneumonia vaccine in her right arm yesterday and the injection site is red, swollen and aches.  She stated that she had hives and the chills.  She tried taking Benadryl and Tylenol-did not really help.  Appt was given to be seen in the office @ 11:30AM on10/08/2020.  There were no hives when she came to the office.  She was not having any issues breathing, joints were aching.  She was instructed to take Benadryl 25mg ever 4 hours as needed and she may take an extra Ativan or 2 if necessary.  She returned on 10/12/2020 and the erythema and swelling at injection site was gone and was not bothering her anymore.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Patient contacted the office on 10/08/2020 and stated that she received the pneumonia vaccine in her right arm yesterday and the injection site is red, swollen and aches.  She stated that she had hives and the chills.  She tried taking Benadryl and Tylenol-did not really help.  Appt was given to be seen in the office @ 11:30AM on10/08/2020.  There were no hives when she came to the office.  She was not having any issues breathing, joints were aching.  She was instructed to take Benadryl 25mg ever 4 hours as needed and she may take an extra Ativan or 2 if necessary.  She returned on 10/12/2020 and the erythema and swelling at injection site was gone and was not bothering her anymore.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Acupuncture, Back disorder, Cough, Guillain-Barre syndrome, Intervertebral disc disorder
Clinical narrative: A few weeks to a month later I developed a nagging cough that lasted for a few months before I developed GBS. I also had severe back issues that resulted in a disc issues
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: A few weeks to a month later I developed a nagging cough that lasted for a few months before I developed GBS. I also had severe back issues that resulted in a disc issues
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: Severe hives for 5 days including angioedema (swollen lips and eyelids) - Ranitidine 150 mg PO twice daily was given + Allegra once daily  180 mg was given + Benadryl 50 mg every 3-4 hours + Prednisone 20 mg once daily  with no relief. I sought care at an allergy/dermatology clinic and was prescribed Prednisone 60 mg PO for several days and then a slow taper over 5 weeks. The hives and itching decreased after 1-2 days of taking the Prednisone.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Patient came on 12-4-2020 at 2:12 pm. She indicated she has never had flu-shot and is first time receiving it.  She felt fine until that night. she indicated she cough for 1/2 hours, sore throat, shortness of breath, fever (102 oF), headache, nausea and dizziness. Her husband took her to the emergency room.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Patient came on 12-4-2020 at 2:12 pm. She indicated she has never had flu-shot and is first time receiving it.  She felt fine until that night. she indicated she cough for 1/2 hours, sore throat, shortness of breath, fever (102 oF), headache, nausea and dizziness. Her husband took her to the emergency room.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Patient had 3 cm induration and an area of redness of about 10 cm in office minutes after receiving the vaccine on the RL
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Started out as usual pain associated with flu shot, then gradually get worsen to tingling down the arm to fingers, and still occuring
Age: 0.58
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Laboratory test, Magnetic resonance imaging, Periarthritis
Clinical narrative: 12/11/2019  caller went in for flu shot at the clinic, nurse gave injection  in the lower left arm.  Caller stated in minutes she had pain after 4 weeks patient had a frozen shoulder. Caller reach out to pharmacy and let them know what was going on .Caller went to see primary doctor who sent caller to OTx12 wks.  Caller stated after 12wks no relief. Doctor sent  patient for MRI and cortisone injection lasted a week.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Supraventricular tachycardia
Clinical narrative: SVT- EKG preformed and treated with metoprolol
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: grabbed hep b child immunations instead of hep b adult
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypoaesthesia, Intensive care, Paraesthesia, Paraplegia
Clinical narrative: Patient's wife reports tingling/numbness in fingers and toes; paralysis of lower half of body; possibly Gillain-Barre Syndrome; ICU admission
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient developed symptoms on 11/5, was hospitalized and diagnosed with guillian barre syndrome.
Age: 1.0
Sex: F
Vaccine: MMRV, PPV, VARCEL
Symptoms: Irritability
Clinical narrative: On 08/12/2020 Patient was given a Proquad and Varicella injection. (Totality not seen clearly on paper submitted to ). Mother notified and Patient did well throughout the night. Patient was a little fussy per mother and received a dose of Tylenol at night.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Sleep disorder
Clinical narrative: Received Shingrix first injection 12/1/2020 Night of injection, slept poorly. In the morning, felt nauseated, tired, headache, and muscle aches. Next day still easily tired with slight headache, but all other symptoms were gone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: About 7 hours after the vaccine, I started to feel draggy and awful.  I became very cold, so I piled on blankets.  I couldn't get warm all night and I felt terrible.  If I hadn't had the vaccine the day before, I would have thought I was getting Covid.  It was scary.  The next morning I took some Advil, and I started to feel human againm but tired and weak.  By 2:30 that afternoon, my stomach was gurgling and I had gas and diarreah.  The cold and now at times hot symptoms returned. The injection site is very sore.  That is the only side effect I thought I was going to experience.  This is awful.  I'm not sure I will go back for the second dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Flatulence, Injection site pain, Nervousness
Clinical narrative: About 7 hours after the vaccine, I started to feel draggy and awful.  I became very cold, so I piled on blankets.  I couldn't get warm all night and I felt terrible.  If I hadn't had the vaccine the day before, I would have thought I was getting Covid.  It was scary.  The next morning I took some Advil, and I started to feel human againm but tired and weak.  By 2:30 that afternoon, my stomach was gurgling and I had gas and diarreah.  The cold and now at times hot symptoms returned. The injection site is very sore.  That is the only side effect I thought I was going to experience.  This is awful.  I'm not sure I will go back for the second dose.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: Two days after receiving the vaccine, patient's arm became red, swollen, and itchy. Patient was seen by her primary care provider and prescribed a steroid dose pack to treat an allergic reaction. Patient's mother stated that patient's arm was better soon after starting dose pack and patient is doing well.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Rash
Clinical narrative: Called patient to remind them that 2nd dose is due.  This was the first time notified by patient that he had a reaction the day after 1st dose.  He had a rash on his hand and was unable to feel or move his arm.  He was admitted to the hospital.  Length of hospital stay not known. Patient has recovered since then.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red circle on right arm. no bump and not warm to the touch
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Screaming, Ultrasound scan normal, X-ray limb normal
Clinical narrative: The shot itself hurt worse than any shot I've ever had in my life. I wailed out in pain.  Within thirty minutes my left shoulder was killing me.  It has not improved at all.  It's painful to drive, to cook, to help my clients, to do anything!
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: After receiving  Pneumovax 23 vaccine, about 2 days  later patient reported to the pharmacy of facial swelling, itching and redness. No trouble breathing or throat swelling.. It was recommended to the patient to seek medical attention. Hydrocortisone was prescribed to patient, which worked. After following up with the patient she stated her redness and swelling has subsided. No other issues reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever of 101.5 for about 18 hours. Shivering. Exhausted.
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated she started to notice some pain in her left shoulder at some time after her shot.  She did not seem to attribute pain to the shot as she was not able to pinpoint a start date, she made a best guess.  She said she thought pain would go away, but it has not resolved with heat or ibuprofen, which is all she has tried to this point.  She has lost range of motion in left shoulder as well.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: During one of our flu vaccine shot-ex events an adult was mistakenly given a pediatric dose (6-35 months Afluria IIV4 0.25ml).  A child was on his lap and the person who drew up the dose thought it was for the child, while the administrator gave it to the adult.  With agreement from the patient, the supervisor on site decided to the give the adult another pediatric dose (2 total).