chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Diagnosed with shingles; Rash on her stomach; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on unknown date in 2009 experienced Shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional deatils were provided as follows: The age vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experienced a rash on her stomach. The patient went to the hospital (not admitted) to check it out and was diagnosed with shingles. The patient had a prior history of shingles in 2009. The patient thought the rash was poison ivy but was diagnosed with shingles. The reporter consent to follow up. This case was linked with case US2020202980 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202980:same reporter
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Cellulitis, Cerebrovascular accident, Facial paralysis
Clinical narrative: Mild stroke; Bell's Palsey; losing weight; cellulitis in left arm; Fever; Rash; extreme weakness; swollen left arm; pain in shoulder; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 69-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 1st August 2020, the patient received Boostrix (intramuscular) .5 ml. On 3rd August 2020, 2 days after receiving Boostrix, the patient experienced cellulitis of arm (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), rash (serious criteria hospitalization), weakness (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and shoulder pain (serious criteria hospitalization). On 9th August 2020, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant) and weight loss (serious criteria hospitalization). On 10th August 2020, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm and shoulder pain were not recovered/not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm, shoulder pain and weight loss to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix in left arm. After Receiving Boostrix, the patient experienced fever, rash, swollen left arm, pain in shoulder and cellulitis in left arm.   He went to the Emergency room and was hospitalized for 4 days and put on antibiotic therapy for the cellulitis.   The patient went home and 2 days later, he suffered a mild stroke and Bell's Palsey.   He ended up going back in the hospital.   The patient reported that the issues were not completely resolved.   He also reported losing weight and extreme weakness.   The patient stated his doctors have said he had a reaction to a contaminated needle and did not think these symptoms were from the Boostrix shot. The reporter did not consent to follow-up. No healthcare professional information was provided.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling, Product contamination, Pyrexia, Rash, Weight decreased
Clinical narrative: Mild stroke; Bell's Palsey; losing weight; cellulitis in left arm; Fever; Rash; extreme weakness; swollen left arm; pain in shoulder; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 69-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 1st August 2020, the patient received Boostrix (intramuscular) .5 ml. On 3rd August 2020, 2 days after receiving Boostrix, the patient experienced cellulitis of arm (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), rash (serious criteria hospitalization), weakness (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and shoulder pain (serious criteria hospitalization). On 9th August 2020, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant) and weight loss (serious criteria hospitalization). On 10th August 2020, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm and shoulder pain were not recovered/not resolved and the outcome of the weight loss was unknown.   It was unknown if the reporter considered the cellulitis of arm, stroke, bell's palsy, fever, rash, weakness, swelling arm, shoulder pain and weight loss to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix in left arm. After Receiving Boostrix, the patient experienced fever, rash, swollen left arm, pain in shoulder and cellulitis in left arm.   He went to the Emergency room and was hospitalized for 4 days and put on antibiotic therapy for the cellulitis.   The patient went home and 2 days later, he suffered a mild stroke and Bell's Palsey.   He ended up going back in the hospital.   The patient reported that the issues were not completely resolved.   He also reported losing weight and extreme weakness.   The patient stated his doctors have said he had a reaction to a contaminated needle and did not think these symptoms were from the Boostrix shot. The reporter did not consent to follow-up. No healthcare professional information was provided.
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Body temperature increased, Cough, Nasal congestion, Pain
Clinical narrative: stuffy nose; coughing; increase in temperature; body aches; This case was reported by a consumer via call center representative and described the occurrence of nasal stuffiness in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 93FR9, expiry date 29th April 2022) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) (batch number 279811, expiry date 30th June 2021) for prophylaxis.   On 8th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD (intramuscular). In October 2020, 20 hrs after receiving Shingrix, the patient experienced nasal stuffiness, cough, body temperature increased and general body pain. On an unknown date, the outcome of the nasal stuffiness, cough, body temperature increased and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the nasal stuffiness, cough, body temperature increased and general body pain to be related to Shingrix.  Additional details were reported as follows: On 8th October 2020, at 1 pm in the right arm the patient received Shingrix and Fluad vaccine in the left arm at the same time and on 9th October 2020 20 hours after vaccines had body aches, increase in temperature by 1 degree, coughing and stuffy nose.  At the time of reporting events was still ongoing but were minor. It was unknown if the reporter considered the nasal stuffiness, cough, body temperature increased and general body pain to be related to FLUAD. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the newer vaccine for bacterial pneumonia; This is a spontaneous report from a contactable consumer (patient). A currently 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for bacterial pneumonia, immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic to the newer vaccine for bacterial pneumonia on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Extra dose administered
Clinical narrative: Prevnar given unnecessarily. Had  4th Prevnar vaccine 7/13/2020.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Headache, Injection site rash, Myalgia, Vertigo
Clinical narrative: Dizzyness, vertigo, headache and muscle aches, rash on arm near shot location
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Swelling face
Clinical narrative: Facial swelling, acute dizziness x1
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dizziness, Hyperhidrosis, Influenza like illness, Injection site pain
Clinical narrative: Severe pain to left arm site of injection, now going on 4 days.  Low grade fever. Mild nausea. Dizziness.  Chills and shaking.  Moderate Sweating. Felt like flu symptons. Have done flu shots for many years and never experienced this level of problems.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Severe pain to left arm site of injection, now going on 4 days.  Low grade fever. Mild nausea. Dizziness.  Chills and shaking.  Moderate Sweating. Felt like flu symptons. Have done flu shots for many years and never experienced this level of problems.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arm still hurts after extended time
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Contusion, Pain
Clinical narrative: big bruis with pain, it came 1 hr after the shot was given
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Anxiety, Dizziness, Tachycardia
Clinical narrative: Dizziness, anxiety , tachycardia within 10 mins of receiving vaccine
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Amnesia, Chest pain, Electrocardiogram normal, Electroencephalogram normal, Impaired work ability
Clinical narrative: Dizziness, anxiety , tachycardia within 10 mins of receiving vaccine
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Influenza like illness, Loss of bladder sensation, Loss of personal independence in daily activities, Lumbar puncture, Paraesthesia
Clinical narrative: Dizziness, anxiety , tachycardia within 10 mins of receiving vaccine
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Sensory loss, Syncope, Tremor, Vision blurred
Clinical narrative: Dizziness, anxiety , tachycardia within 10 mins of receiving vaccine
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Dehydration, Feeling abnormal, Immediate post-injection reaction, Oxygen saturation decreased, Syncope
Clinical narrative: FLU SHOT 10/12/2020:  the following is per phone call with patient on 10/13/2020  ; Patient received Flucelvax vaccine (Fluad oos)  on 10/12/2020 and 45 minutes later while shopping fainted ; ambulance was called and patient went to hospital for observation ; pt has hx of orthostatic hypotension, was found to be dehydrated, and had low O2 saturation ; pt reported no arm pain or trouble breathing post vaccine but had a "funny feeling" immediately after vaccine administration (which was not reported to RGA until follow up phone call) ; patient didnt think the vaccine was the direct cause of the fainting but may have "put her over the top for the day" ; advised patient to get flu shot at provider's office next year so she can be monitored (if vaccine is without event said she could resume vaccinations with our pharmacy)
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Contusion, Loss of consciousness
Clinical narrative: HPV & Flu vaccine administered in Both thigh pt stood up and passed out; Hit trash can Bruise on Left eyebrow
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Expired dose of Pneumovax23 administered; This spontaneous report was received from a pharmacist reporting about a patient of unknown age and gender. Information about the patient's medial history, concurrent conditions or concomitant medications was not reported.      On 02-OCT-2020, the patient was inadvertently vaccinated with 1 expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S025133, expiration date 15-SEP-2020, for prophylaxis. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; the patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies.  On 10-OCT-2020, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133, expiration date: 15-SEP-2020) dose reported as 1 shot (dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event details were provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Rash, Rash macular
Clinical narrative: Soreness at the injection site; and a "splotchy" Rash on her torso; Malaise or "not feeling well"; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic reaction to drug (allergic to NSAIDS).   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, rash and malaise. On an unknown date, the outcome of the injection site pain, rash and malaise were unknown.   It was unknown if the reporter considered the injection site pain, rash and malaise to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received first Shingrix vaccine approximately one week before time of reporting. The patient reported soreness at the injection site, Malaise or not feeling well, and a splotchy rash on her torso.  She stated that she was allergic to NSAIDS, and she had the exact same rash if she took an NSAIDS. The reporter did not consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Fatigue, Hypersensitivity, Nausea
Clinical narrative: patient reported reaction similar to when a patient eats chickpeas and sesame seeds; nausea; trouble swallowing/similar to when a patient eats chickpeas and sesame seeds; fatigue; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number C47FY, expiry date 16th September 2022) for prophylaxis.   Concurrent medical conditions included food allergy (patient had reaction to chickpeas and sesame seeds).   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th October 2020, 1 hr after receiving Shingrix, the patient experienced allergic reaction, nausea, swallowing difficult and fatigue. On 6th October 2020, the outcome of the nausea, swallowing difficult and fatigue were recovered/resolved. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction, nausea, swallowing difficult and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received the dose and one hour later the patient reported reaction similar to when a patient eats chickpeas and sesame seeds. Patient reported trouble swallowing, fatigue and nausea, and all symptoms were resolved within a few hours.  Patient did not need to use Epipen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: aches; felt tired; had "flu like symptoms"; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old 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 months after receiving Shingrix, the patient experienced pain, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain, tiredness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: This case was reported by a patient for herself. Lot and expiration date were not provided. Two months ago, from the date of reporting the patient received 1st dose of Shingrix. The patient experienced aches, felt tired and had flu like symptoms that last 36 hours. Customer disconnected abruptly and did not provided additional information. The reporter did not consent to follow-up. Further tolerance for the 2nd dose of Shingrix refer case US2020AMR202070, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202070:same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Optic neuritis
Clinical narrative: retrobulbar neuritis; This case was reported by a physician via call center representative and described the occurrence of retrobulbar neuritis in a 56-year-old female patient who received HBV (Engerix B) (batch number 5397F, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis (patient has multiple sclerosis and was stable for 12 years).   On 3rd August 2020, the patient received Engerix B (intramuscular). On 4th August 2020, the patient received Shingrix (intramuscular). On 14th August 2020, 11 days after receiving Engerix B and 10 days after receiving Shingrix, the patient experienced retrobulbar neuritis (serious criteria GSK medically significant). On an unknown date, the outcome of the retrobulbar neuritis was unknown.   It was unknown if the reporter considered the retrobulbar neuritis to be related to Engerix B and Shingrix.  Additional details were reported as follows: The reporter was the patient's physician but not the physician who administered Engerix. On 3rd August 2020, patient received Engerix intramuscularly and on 4th August 2020, shingrix intramuscularly in opposite arm and on 14th August 220, experienced retrobulbar neuritis. The reporter mentioned that, patient has multiple sclerosis and was stable for 12 years. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: 2 family members died after getting vaccine; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional via social media.  This case is linked to cases 2020SA282978 and 2020SA282955 (same reporter).  This case involves two patients who died after they received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the reporter's family members died (death) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.   Other relevant tests were not reported.  It was not reported if the patients received any corrective treatment before death.  It was unknown if an autopsy was done and cause of death was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns two patients of unknown age who died after vaccination with INFLUENZA VACCINE (produced by unknown manufacture). The time to onset was unknown. However, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based on the limited information available, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death
Sex: F
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: deathly ill with the flu until it finally killed her; Initial information received on 07-Oct-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional via public post on the Sanofi flu shot campaign.   This case involves female patient (unknown age) who was deathly ill with the flu until it finally killed her (influenza), while she received INFLUENZA VACCINE.  The patient's past vaccinations included flu shots (INFLUENZA VACCINE) every year and every year she was deathly ill with the flu.  Concomitant medication(s), medical treatment(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 were not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was deathly ill with the flu and that it finally killed her (influenza) (serious) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome of the event Influenza was fatal as the patient died due to it on an unknown date.  It was not reported whether the autopsy was done or not and the cause of death was reported as Influenza.  Information on the batch number to be requested.; Sender's Comments: A case was reported which involves a female patient of unknown age who died due to influenza, after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. The patient used to have flu shots every year and had got ill every time in the past. Additional information regarding patient's relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results is needed for complete assessment of the case. Thus, a role of the vaccine could not be assessed.; Reported Cause(s) of Death: deathly ill with the flu until it finally killed her
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: symptoms similar to Guillain-Barre syndrome; Initial information was received on 30-Sep-2020 regarding an unsolicited valid serious case from a non-health care professional.  This case involves a 79-year-old female patient who experienced symptoms similar to Guillain-Barre syndrome (Guillain-Barre syndrome), while she received vaccine INFLUENZA VACCINE   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious symptoms similar to Guillain-Barre syndrome (Guillain-Barre syndrome), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported that, the patient was never diagnosed with Guillain-Barre, but the doctors started giving her a half dose of the flu shot one day and the rest another day.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  Information on the batch number requested.; Sender's Comments: This case concerns a 79-Year old patient who had Guillain-Barre syndrome, after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. There is no information regarding the patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies. Based on the limited information available, the role of the vaccine could not be assessed.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discolouration, Pain
Clinical narrative: Patient has big blackish mark surrounding the injection site and has feeling throbbing pain. As per talk on 10/14/2020 @ 2:40PM, Patient is feeling very unusual pain. Recommended to see the doctor.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pt was given Pediatric dose of Hep B instead of Adult dose as her 3rd dose.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states that her arm got really swollen and red and painful and was difficult to move for a couple of days. She states that the reaction has now gone way down and she feels better.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Bursitis, Inflammation, Pain
Clinical narrative: pt reported to pharmacy of shoulder pain lingering for a few weeks after receiving flu shot. after seeing orthopedic md, md diagnosed her with bursitis from flu vaccination. md prescribed meloxicam to help with inflammation and pain. pt reported to pharmacy during vaccination administration, pharmacist was standing and may have administered it too high on the deltoid muscle.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Employee received a high-dose vaccine and was <65 years old. No adverse outcome.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chest pain, Electrocardiogram normal, Fatigue
Clinical narrative: Severe Chest pain radiating to back.  lasting approx 30 minutes.    approx 6 hours later, pt experienced severe lumbar back pain with bilateral leg pain, headache, nausea and weakness. Weakness and fatigue continued.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Severe Chest pain radiating to back.  lasting approx 30 minutes.    approx 6 hours later, pt experienced severe lumbar back pain with bilateral leg pain, headache, nausea and weakness. Weakness and fatigue continued.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patients mother reported site hot, red and painful after shot. started day of shot.  Picture was taken, look like possible cellulitis.  Told patients mother to take see MD to get course of anti-biotics.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Nausea, Pallor, Posture abnormal, Syncope
Clinical narrative: Syncopal episode with loss of consciousness x 3 minutes:  Patient became pale and complained of nausea. Head slumped forward.   Unable to arouse x 3 minutes.  Patient placed supine, ice pack applied.  Initial BP at time of incident 1:15 pm was 79/47.  BP at 1:25, 109/63.  Patient given juice.  Sat up on side of bed at 1:30pm without incident.  Patient walked with mother from facility at 1:40pm.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Syncopal episode with loss of consciousness x 3 minutes:  Patient became pale and complained of nausea. Head slumped forward.   Unable to arouse x 3 minutes.  Patient placed supine, ice pack applied.  Initial BP at time of incident 1:15 pm was 79/47.  BP at 1:25, 109/63.  Patient given juice.  Sat up on side of bed at 1:30pm without incident.  Patient walked with mother from facility at 1:40pm.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Significant soreness in arm, pain ,stiffness, Went to see her physician, presented with a raised patch at injection site that was painful & warm to the touch. Physician believed the patient had cellulitis and prescribed antibiotics for 7 days as well as prn Benadryl for the inflammation
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Significant soreness in arm, pain ,stiffness, Went to see her physician, presented with a raised patch at injection site that was painful & warm to the touch. Physician believed the patient had cellulitis and prescribed antibiotics for 7 days as well as prn Benadryl for the inflammation
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Before the end of the day she had what she described as severe swelling and soreness around the injection site and upper arm.  It persisted until she called the pharmacy to report the swelling 24 hours later.  The pharmacist advised her to take Benadryl and watch it for worsening or spreading.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported with swollen, erythematous, painful, hot to the touch skin at injection site.  Began after injection
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Local reaction, Myalgia, Skin warm, Swelling
Clinical narrative: local reaction red raised warm 4 cm in diamater followed by continued deltoid pain
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Epistaxis, Immune thrombocytopenia, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: My daughter received her vaccines on 5/12/20 at 12 months old. She had a virus on  5/2-5/4-20 with a 104-105 degree fever with no other symptoms. She was cleared for her vaccines on 5/12/20 since no fever was present. On 5/28/20 she started getting a rash then got petechiae and had a nose bleed the morning of 5/29/20. I took her to the pediatrician who immediately sent us to have a platelet count at the hospital. The Platelet count came back at 2,000 and we immediately went to the ER.  After more testing and a few questions on other counts they ruled out Leukemia. The Doctors told me it was ITP most likely caused by the MMR vaccine in addition the active virus from 5/2/20. After a platelet transfusion her platelet levels increase and a month later they were back to normal.  They did warn me that she could possibly have reactions to other vaccines and their was  a small chance she could develop an autoimmune disorder from the ITP.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: My daughter received her vaccines on 5/12/20 at 12 months old. She had a virus on  5/2-5/4-20 with a 104-105 degree fever with no other symptoms. She was cleared for her vaccines on 5/12/20 since no fever was present. On 5/28/20 she started getting a rash then got petechiae and had a nose bleed the morning of 5/29/20. I took her to the pediatrician who immediately sent us to have a platelet count at the hospital. The Platelet count came back at 2,000 and we immediately went to the ER.  After more testing and a few questions on other counts they ruled out Leukemia. The Doctors told me it was ITP most likely caused by the MMR vaccine in addition the active virus from 5/2/20. After a platelet transfusion her platelet levels increase and a month later they were back to normal.  They did warn me that she could possibly have reactions to other vaccines and their was  a small chance she could develop an autoimmune disorder from the ITP.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt accidently received a third dose of the Hepatitis A vaccine. No adverse effects. pt mother was notified about the injection. No harm expected for the patient in receiving an extra dose per PCP.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to pharmacy looking for his 2nd shingrix shot.  Administered vaccine and patient left.  Patient's primary MD called 10/14/20 to discuss the patient's vaccine history because her records indicated that was his 3rd dose.  Upon further investigation the patient received 4 total doses.  1st: 6/12/18, 2nd: 9/27/19, 3rd: 7/13/20, 4th: 10/12/20.  Patient has not called to report any adverse symptoms.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Injection site haematoma, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: Administration of flu vaccine, GSK Fluarix, LOT# N549A, left deltoid, IM injection. This person was given their first flu shot in an observed mass clinic, drive-thru vaccine clinic setting. The patient experienced an instant swelling of the upper left arm at the injection site. It is believed to be an instant hematoma at the injection site. Underneath the skin was slightly swollen, and slightly purple. There was a little more blood than usual with this injection. The RN wiped away blood and held pressure. Then another nurse was called and held pressure for 5 minutes to make sure the bleeding stopped and slow the swelling. The patient complained of pain at the injection site. She said "I could feel it going in more than I thought I would." This was her first flu vaccine ever.  Patient did not appear to have any additional swelling after approximately 3 minutes post-injection.  It did not appear to be worsening. Overall, pressure was held over the site for about 7 minutes.  Patient was given an ice pack and advised to keep rotating ice off and on the site as tolerable to decrease the swelling.  The patient did not appear to have symptoms of respiratory distress or anaphylaxis. Patient appeared otherwise healthy after injection.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Skin swelling
Clinical narrative: Administration of flu vaccine, GSK Fluarix, LOT# N549A, left deltoid, IM injection. This person was given their first flu shot in an observed mass clinic, drive-thru vaccine clinic setting. The patient experienced an instant swelling of the upper left arm at the injection site. It is believed to be an instant hematoma at the injection site. Underneath the skin was slightly swollen, and slightly purple. There was a little more blood than usual with this injection. The RN wiped away blood and held pressure. Then another nurse was called and held pressure for 5 minutes to make sure the bleeding stopped and slow the swelling. The patient complained of pain at the injection site. She said "I could feel it going in more than I thought I would." This was her first flu vaccine ever.  Patient did not appear to have any additional swelling after approximately 3 minutes post-injection.  It did not appear to be worsening. Overall, pressure was held over the site for about 7 minutes.  Patient was given an ice pack and advised to keep rotating ice off and on the site as tolerable to decrease the swelling.  The patient did not appear to have symptoms of respiratory distress or anaphylaxis. Patient appeared otherwise healthy after injection.
Age: 7.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, HPV9, IPV, MMR, PNC13
Symptoms: Body temperature increased, Inflammation, Pain in extremity
Clinical narrative: at a childhood immunization clinic, the nurse gave eleven vaccines to the child.   the child experienced a sore arm with inflammation and an elevated temperature the evening of the vaccinations, but was reported fine the next day.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Abscess
Clinical narrative: Developed an abscess two days after injection, abscess has grown bigger than a quarter in 2 months
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Local reaction, Pyrexia, Swelling, Tenderness
Clinical narrative: localized reaction of erythema, swelling, tenderness and fever with max temp of 103
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Shot was administered rather high on arm which he noticed when he went to remove bandaid - arm hurt that day and has not gotten any better-the first week he could not raise his arm - he can raise it now but it really hurts - he describes it as feeling like something is out of joint.  Has not taken any NSAIDS as of yet
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Pt received vaccine and experienced syncope about 10 minutes later.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site pain, Injection site ulcer
Clinical narrative: Pt  returned to clinic on 10-13-2020 for black spot, redness on right upper arm where pneumococcal vaccine was placed.  Pt states that arm had soreness, redness and swelling the same day as the injection, on 9-28-2020.  Pt states that she developed an ulcer to the area one week after the injection.    She contacted the clinic on 10-12-2020 to notify of the reaction and returned to our office on 10-13-2020; finding by provider were 25 X 10mm black eshcar over the lateral aspect of the right upper arm with surrounding erythema and tenderness.  Pt was prescribed cephalexin 500mg every 12 hours orally for 10 days and also given instructions on wet to dry dressing changes daily.  A moist dressing was applied in the clinic.  Pt scheduled to follow up in one week.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site eschar
Clinical narrative: Pt  returned to clinic on 10-13-2020 for black spot, redness on right upper arm where pneumococcal vaccine was placed.  Pt states that arm had soreness, redness and swelling the same day as the injection, on 9-28-2020.  Pt states that she developed an ulcer to the area one week after the injection.    She contacted the clinic on 10-12-2020 to notify of the reaction and returned to our office on 10-13-2020; finding by provider were 25 X 10mm black eshcar over the lateral aspect of the right upper arm with surrounding erythema and tenderness.  Pt was prescribed cephalexin 500mg every 12 hours orally for 10 days and also given instructions on wet to dry dressing changes daily.  A moist dressing was applied in the clinic.  Pt scheduled to follow up in one week.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: GI effects (Nausea/Vomiting)  Starting the day after immunization and continuing  for 5 days.  (Lost 7 lbs in 3 days) Treated for vomiting at Emergency Department per recommendation of primary care physician. Dizziness and lightheadedness. Headache Symptoms resolved after 5 days.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Mouth swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Throat, tongue, mouth swollen.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness with streaking down left arm. Onset began within 24 hours of vaccine being administered.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea, Headache, Myalgia, Nausea, Wheezing
Clinical narrative: I have had trouble breathing,  wheezing,  headaches, nausea, muscle aches.  None of which I had the day before.  I have had to go on an inhaler the last week as I am not improving.  My breathing was fine prior to the shot and I am getting worse.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash pruritic
Clinical narrative: Approximately 3 weeks after flu shot, a very itchy (but not painful) rash appeared on my chest area.  As days went on, the rash moved to areas of my body:  around my underarms (but not in it); on my outer elbows (not inner); the entire waist area of my stomach; my inner thighs (this is where it was the worst); the inside of my knees.  It took approximately 4-6 weeks before the rash disappeared and was extremely itchy.  I receive a flu shot every year and have for several years in a row, never skipping.  I have never experienced any allergies or rashes in my life until this happened.  After several weeks attempting to clear rash with OTC products, I went ahead and  notified my doctor and the pharmacist of what I believe "may" be linked to this flu shot.  Please note:  I really, really like the pharmacy I get my prescriptions from and the people who work there.  I do not in any way wish to point the finger at them.  I only wish to alert you to this reaction and to possibly check on the manufacturer flu shots the pharmacy uses.  Thank you for this consideration.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 100.3 for 2 days, severe muscle soreness and fatigue for 36 hours, general fatigue for 48 hours.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: she reported the arm was red-swollen and hurt- she use ice and ibuprofen- for 4 days
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient appeared to lose consciousness  for a moment after exciting the consultation room where the vaccine was given ( about 2 mins after the vaccination). His dad was able to catch him before he fell completely to the ground.  We seated him and had him put his head forward.  I gave him a sip of water. He sat in our waiting area for about 10 more minutes.  He and his father said he was okay prior to leaving the facility. His sister commented to me that he may have a fear of needles.  I called the phone number given on the consent form about 2 hours after the incident to follow up to verify that patient had fully recovered. . I left a message and have not yet received a return call.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fibrin D dimer increased, Peripheral swelling
Clinical narrative: Swelling, redness with streaking down left arm. Patient had a positive D-Dimer was referred to Emergency Department from Urgent Care but US was negative at ER.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: PATIENT HAD FEVER THE NIGHT OF ADMINISTRATION
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness
Clinical narrative: Patient was leaving store after receiving her vaccination and began experiencing dizziness and confusion, causing her to move to the floor. Emergency services were contacted, and she was transported to the hospital. She had received HD flu vaccines in 2018 and 2019 with no known adverse events. The incident was witnessed by another customer.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Patient called me today to let me know she experienced nerve pain down to her right heel after her flu shot.  The injection site had no soreness other than the day of.  She is a retired ER nurse and said my technique was fine and I gave it to her in the right location.  She is thinking something in this year's Fluad didn't agree with her system.  Also her husband was given the same exact shot and he had no reactions.  She wanted to let me know.  She is considering the none senior dose next year to avoid this from happening again.  Also she wanted the lot number to report to CDC.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Small amount of of soreness after shot and that evening she noted some tenderness and maybe pale colored skin in the area of the injection.  However, there was no warmth swelling or redness.  The next morning she noted the area had increased in size slightly and was red warm and tender to touch.  Later on that day she noted the area enlarged and was now red.  It remained warm to touch, mildly tender and raised.  There is no itching.  The areas well defined.  There is no streaking.  The areas continue to slowly advanced to its current position.  She has not had any fever myalgias arthralgias.  No wheezing shortness or breath or headaches.  Her appetite has been good.  There is no pain or soreness in other areas outside of this reaction site.  There has been no skin trauma to the area.  She had a very similar though less intense reaction after she got her 2nd shingles vaccine though it is less red tender and warm, and is not as extensive.  The patient ultimately treated this with a course of antibiotics and resolved.  She has no previous history of reaction to influenza or Pneumovax vaccine.  She has no history of egg allergy.
Age: 24.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Malaise, Pallor, Syncope
Clinical narrative: Patient first received Adacel in left arm - had no reaction. Then about 1 minute later patient  received Fluzone in right arm - within about 30 seconds reported not feeling well - was pale and proceeded to have a syncope event. Patient was kept in chair with head supported - tried to get her on her back on the floor in order to elevate feet, but she stated she was feeling better - this happen all within about 3 minutes. Gave her water - since she was feeling better, she denied a cool compress and did not end up laying on floor, although it was suggested.  Patient looked as if she was holding breath  during shots - unknown regarding last time she ate. Patient did state she did not have allergic reaction to shots in the past.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Head injury, Skin laceration, Suture insertion, Syncope
Clinical narrative: Patient experience a syncopal episode in which he hit his head requiring a laceration.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Pt noted red spots and soreness on side of arm (not at area of injection).  No itching, just tender to the touch.  slightly red in appearance (almost like hives but sore, not itchy).  99 fever
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient describes swelling and redness in the right arm, warm to the touch with a weal that is only now getting better. She reported this today, a week later. Patient never went to the doctor, just wanted a report made on her profile.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever 99.8 within 3 hours, chills, nausea, fatigue lasting about 30 hrs