chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: - headache began at 10 pm on 10/12/20 - 10/13  developed 102.3 f fever, chills, dizziness, left deltoid redness, swelling, warmth, pain, headache - 10/15 continues to have headache and fatigue and left arm pain/redness/swelling but no fever. no history of prior vaccine reaction
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site inflammation, Injection site swelling, Peripheral swelling, Swelling face
Clinical narrative: Patient experienced inflammation at the injection site, as well as swollen arm down to hand, and face. Redness also. Contact administering nurse for further information
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Joint range of motion decreased, Muscle strain, Neck pain, Pain
Clinical narrative: Patient woke with pain in the L lateral neck on 10/3/2020, approximately 24 hours after vaccine administered in L deltoid. No pain in shoulder at this time. Neck pain initially described as mild and able to continue with normal activities. Went to gym on 10/5/2020 and able to complete normal exercise routine . Pain increased over the following  days. Pain began to radiate to L occipital region on 10/9/20 and woke patient from sleep, Also difficult to turn head to the side at that time. Denies  paresthesia, weakness at any point. Patient contacted this provider (administered the vaccine) and her PCP on 10/9/2020. Per patient report, discussed symptoms with her PCP via patient messaging portal. States physician did not feel that pain was due to immunization but was likely due to neck strain. As patient reported temporal concern regarding onset neck pain and this injury, report made to VAERS by the administering provider,  in the case there should there be an underlying association. At follow up with patient today 10/15/2020, pain has improved and full ROM in neck. No symptoms in the arms. No headache. Patient is aware report made to VAERS.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Patient woke with pain in the L lateral neck on 10/3/2020, approximately 24 hours after vaccine administered in L deltoid. No pain in shoulder at this time. Neck pain initially described as mild and able to continue with normal activities. Went to gym on 10/5/2020 and able to complete normal exercise routine . Pain increased over the following  days. Pain began to radiate to L occipital region on 10/9/20 and woke patient from sleep, Also difficult to turn head to the side at that time. Denies  paresthesia, weakness at any point. Patient contacted this provider (administered the vaccine) and her PCP on 10/9/2020. Per patient report, discussed symptoms with her PCP via patient messaging portal. States physician did not feel that pain was due to immunization but was likely due to neck strain. As patient reported temporal concern regarding onset neck pain and this injury, report made to VAERS by the administering provider,  in the case there should there be an underlying association. At follow up with patient today 10/15/2020, pain has improved and full ROM in neck. No symptoms in the arms. No headache. Patient is aware report made to VAERS.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site was sore and slightly swollen the night of the injection    The next morning the injection site was red in rectangular shape about 4" x 2" and was swollen.  After breakfast and shower felt very nauseous and faint.  Vomited twice and was very weak and woozy.  Drank water and orange juice.  Laid down for a few hours.  Was able to eat some soup at lunch and started to feel better.  Was also able to have soup again at dinner.  Next morning (about 40 hours after injection  was feeling much better (no nausea) but injection area is still a bit swollen and the red/pink area around injection is lighter in color, longer (about 6 inches toward armpit), and is still quite sore to the touch.  I had no adverse reaction when I had my first Shingles injection about one year ago.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Injection site was sore and slightly swollen the night of the injection    The next morning the injection site was red in rectangular shape about 4" x 2" and was swollen.  After breakfast and shower felt very nauseous and faint.  Vomited twice and was very weak and woozy.  Drank water and orange juice.  Laid down for a few hours.  Was able to eat some soup at lunch and started to feel better.  Was also able to have soup again at dinner.  Next morning (about 40 hours after injection  was feeling much better (no nausea) but injection area is still a bit swollen and the red/pink area around injection is lighter in color, longer (about 6 inches toward armpit), and is still quite sore to the touch.  I had no adverse reaction when I had my first Shingles injection about one year ago.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Pruritus, Urticaria
Clinical narrative: Patient reported about 30 minutes after the shot administration an allergic reaction including redness on trunk chest and back itching and hives developed, also redness at injection site. He took a 50mg benadryl and contacted the pharmacy and his physician to make them both aware. He will follow up with subsequent symptoms and or resolution.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Severe Headache and spine pain leading into 48 hours extreme fatigue, shivering, excruciating joint and muscle pain
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Spinal pain
Clinical narrative: Severe Headache and spine pain leading into 48 hours extreme fatigue, shivering, excruciating joint and muscle pain
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain at the injection site within 24 hours of administration
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia, Rash, Skin warm
Clinical narrative: patient developed a fever, feeling of unwellness and rash one day after receiving the vaccine. the rash is about 6in by 6in, round and is warm to the touch. advised patient that i would alert her md to the reaction and to contact them if she develops another fever or rash worsens
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Malaise, Pruritus, Rash
Clinical narrative: Received vaccination and within approximately and hour began to feel ill, went home, took Benadryl, shortness of breath, rash, itching, worsened overnight.
Age: 44.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain at injection site within 24 hours of injeciton
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage, Paraesthesia
Clinical narrative: Patient reported back to the pharmacy on 10/15/2020 that ever since she received the adacel vaccine,  she has been experiencing "pins and needles" in hand (same arm as vaccine). She states its mainly in the evening when she lays down. However, she it "comes and goes during the day in her arm as well". It started the same night she received the vaccine, and has continued to persist. She also stated that she had bleeding at the injection site for several days after she received the vaccine. At the time of the vaccine, she had some bleeding as well, which prompted me to ask " are you taking fish oils or vit. e"?, which she replied "yes" to vit. e
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: fever the next day after getting flu shot.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Illness, Myalgia, Pyrexia
Clinical narrative: patient reported acute illness of about 2 weeks of fever/chills after second dose. muscle and joint aches have persisted until now
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse and refers to a 11-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 07-OCT-2020, the patient was vaccinated with an improperly stored vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S010729, expiration date 01-DEC-2021, 0.5 milliliter for prophylaxis (route of administration and anatomical location were not reported). The registered nurse reported that the vaccine underwent a temperature excursion of 11.3 degrees Celsius for 55 minutes. There was no previous temperature excursion. A digital data logger was involved. No product quality complaint (PQC) reported.  This is one of two reports received from the same reporter. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Unknown; 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-009507513-2010USA002752:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect reported; expired vaccine administered; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported.     On 08-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number S025133, expiration date 15-SEP-2020), as prophylaxis (expired product administered) (strength, dose, frequency, route of administration and anatomical vaccination site were not provided). No additional adverse effects were reported. The outcome of expired product administered and it's causal relationship with the vaccine were unknown. 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: VARZOS
Symptoms: Rash
Clinical narrative: rash on my torso; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient wanted to know that the rash on torso that patient had to the 1st Shingrix shot was considered an allergic reaction. No further information was reported.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Reported Shingles one week after receiving Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The healthcare professional reported that one week after the vaccination patient experienced shingles. The consumer reported to the physician on 23rd September 2020, he received the vaccine approximately two weeks ago. The reporter did not consent to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Sepsis
Clinical narrative: He has had invasion local disease a blood infection that almost killed him; He has had invasion local disease a blood infection that almost killed him; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 38-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. Caller later stated on the call, patient also smoked, He also had asthma and there was a history obese. Not extremely he's got a big belly everything else was not obese but his belly's big he was also told he may have a heart issue. The patient's concomitant medications were not reported. The patient's significate other called on behalf of the patient seeking assistance with the medication pneumococcal 13-val conj vac (dipht crm197 protein). During the call, patient had invasion local disease a blood infection that almost killed him. He was afraid he's going to die if he contract another blood bourne illness from the local disease. Outcome of events were unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: reported hard lump and itchiness/It is red hard and itchy/3 inch red lump on the location of the injection; reported hard lump and itchiness/3 inch red lump on the location of the injection; reported hard lump and itchiness/It is red hard and itchy/3 inch red lump on the location of the injection; This is a spontaneous report from a contactable other hcp (pharmacy intern calling on behalf the pharmacy). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot/batch number and expiry date unknown) via an unspecified route of administration on 07Oct2020 at 0.5 ml, single dose for immunization. There were no concomitant medications, other conditions and investigation. She said the adverse event was about a 3 inch red lump on the location of the injection from an unspecified date in Oct2020. The injection was administered on Wednesday 07Oct2020 and the lump has persisted until today 13Oct2020, so about a week later. It was red hard and itchy. It has persisted about the same. The reporter asked that how long to wait before seeing a specialist. She did not know the lot expiration at this time. She thought the dose was the 0.5 ml one-time injection. The reporter thought that it was given based on age or guidelines. She believed the patient came in wanting to have their Prevnar 13 completed. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: PNC13
Symptoms: Induration, Mass, Pruritus
Clinical narrative: hard lump; itchiness; This is a spontaneous report from a contactable healthcare professional and a pharmacist. A patient of unspecified age and gender started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 07Oct2020 at single dose for immunization. Medical history and concomitant medications were not reported. Patient experienced a hard lump and itchiness on an unspecified date. Patient was coming in to be seen by the pharmacist and sent to primary care based on recommendation. Outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Immunisation, No adverse event, Product storage error
Clinical narrative: Vaccine had a temperature excursion of 50F and was given to the patient, no adverse event; patient received the vaccine early in her pregnancy with no adverse event; Initial information was received on 22-Sep-2020 regarding an unsolicited non-serious valid case received from a nurse.  The case involved 34-year-old female patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] during pregnancy (Exposure during pregnancy) after the vaccine had a temperature excursion of 50F (Product storage error) .   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 31 weeks of pregnancy. The date of last menstrual period was reported as 04-Jan-2020. The estimated due date is 10-Oct-2020.  Relevant medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication not reported.  On 12-Aug-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6621BA, expiry date 21-Mar-2022) via intramuscular route in the left deltoid for prophylactic vaccination. This was a case of actual medication error due to product storage error. This was a case of vaccine expoure during pregnancy.  Reporter stated that the patient had the vaccine that was part of an excursion and should not have been vaccinated. The reporter inquired time duration for the baby to be covered by the vaccine once administered and if the patients that received the vaccine during pregnancy and have delivered need to be re-vaccinated. The patient was revaccinated (repeat dose) on 21-Sep-2020 at 37 weeks of gestation. (dosing details not reported). At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 69 year old female patient received a expired dose of FLUBLOK , no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 69 year old female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 03-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1964 and expiry date: 30-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre; This spontaneous case was received on 06-Oct-2020 from other non-health professional via Novartis (reference number: NUS2020US120173) and concerned patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported  On an unknown date, the patient was vaccinated with Influenza virus vaccine polyvalent (no generic name; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unknown date, an unknown amount of time after vaccination with Influenza virus vaccine polyvalent, the patient developed Guillian Barre.   The outcome of the event was not reported.  The reporter assessed the event to be related to Influenza virus vaccine polyvalent, as it was reported that it was linked to a flu vaccine.  The event of 'Guillian Barre' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked to 202004618 (the same reporter).  Company comment: A patient of an unknown age developed Guillain Barre syndrome an unknown amount of time after vaccination with Influenza virus vaccine polyvalent. Chronology needs more clarification. The patient's medical history and concomitant medications were not reported. With information available, causal role of the suspect vaccine is assessed as possibly related since GBS is known to be associated with vaccine administration and no alternative aetiology was provided.; Reporter's Comments: It was linked to a flu vaccine.; Sender's Comments: A patient of an unknown age developed Guillain Barre syndrome an unknown amount of time after vaccination with Influenza virus vaccine polyvalent. Chronology needs more clarification. The patient's medical history and concomitant medications were not reported. With information available, causal role of the suspect vaccine is assessed as possibly related since GBS is known to be associated with vaccine administration and no alternative aetiology was provided..
Sex: M
Vaccine: FLUA4
Symptoms: Injection site scab, Neoplasm malignant
Clinical narrative: Malignant carcinoma; Scab appeared in the arm in the same injection site; This spontaneous case was received on 07-Oct-2020 from a pharmacist via Agency (reference number: SEQW20-03046), processed together with additional information received on the same day and concerned elderly male patient of an unknown age. The patient was 91 years old at the time of initial reporting.  The patient's past medical history included skin cancer in his leg. The patient's concomitant medications were not reported.  On 18-Oct-2019, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 263073 and expiry date: 03-May-2020.  On an unknown date, after receiving Fluad Quadrivalent, the scab appeared in the arm in the same injection site. The scab never went away.  On an unknown date in 2020, after a year, the patient went to the doctor, who diagnosed him with a malignant carcinoma. The doctor removed the cells. The pharmacist was not certain but believed that the patient was ok and to her knowledge, the carcinoma had not spread.  The outcome of the events was not reported.  The event of malignant carcinoma was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  Company comment: Neoplasm malignant and vaccination site scab are associated with the use of the suspect product - Fluad Quadrivalent. Chronology is unclarified for vaccination site scab and unsuggestive for neoplasm malignant. The patient's past medical history included skin cancer in his leg while concomitant medications were not reported. Causality is assessed as possibly related for vaccination site scab and unrelated for neoplasm malignant due to reported confounder.; Sender's Comments: Neoplasm malignant and vaccination site scab are associated with the use of the suspect product - Fluad Quadrivalent. Chronology is unclarified for vaccination site scab and unsuggestive for neoplasm malignant. The patient's past medical history included skin cancer in his leg while concomitant medications were not reported. Causality is assessed as possibly related for vaccination site scab and unrelated for neoplasm malignant due to reported confounder.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling started 5 hours after injection in left upper arm. Increasing swelling and  redness for a next two days. Seen on October 2, 2020  in office. At time swelling and redness decreased but required steroids for 3 days. Resoled symptoms. Follow up visit on October 12, 2020.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Heart rate increased, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: 14:33 pm- Individ. receives flu shot injection 14:43 pm- Individ. is observed to tolerate injection well. Upon receiving verbal report of denial of symptoms she is allowed to leave designated monitoring area. 15:05 pm- Individ. returns to clinic and reports of tingling of face and indicates her lip area. Pt. is seated and vital signs taken with only abnormal reading an of elevated HR of 117 bpm.  Pt. is escorted to quiet area and is laid down on a couch and legs are elevated. Pt. reports additional symptom of " my feet were not in control in walking over".   Epi pen placed on standby. 911 phone call placed. 15:19 pm- VS> retaken and measurement of HR as 82 bpm. 15:22pm- Fire dept. and ambulance team arrives. Pt. confirms tingling of face with is now experiencing numbness of tongue. Crew takes VS with examination of possible rash- no abnormal findings.  15:30 pm- Individ. is monitored. 15:45 pm- Pt. declines ambulance transport to ER. Emergency crew departs. 14:00 pm- Pt. is escorted to Urgent Care for further follow-up by fellow RN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod sting, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Fever over 100.5 for 50 hrs, over 101.5 for 12 hrs. Fatigue, nausea, anorexia, severe muscle aches. Painful, Swollen red arm appeared stung by bee.  Headache for three days
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever over 100.5 for 50 hrs, over 101.5 for 12 hrs. Fatigue, nausea, anorexia, severe muscle aches. Painful, Swollen red arm appeared stung by bee.  Headache for three days
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: itchy, redness
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood pressure decreased, Lethargy, Loss of consciousness, Syncope
Clinical narrative: Syncope. She was in the waiting room and passed out. She woke up within seconds but seemed lethargic. She was brought to a room. Vitals were obtained and wnl except for a low BP of 60/40.  She had not had anything to drink yet today, and we gave her water. Within 10 minutes, BP was repeated and up to 92/50. She felt much better, and mom brought her home via her car.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pain, Paraesthesia, Pyrexia
Clinical narrative: Injection site swelling. Sore achy body. Fever.  (Day after initial injection)  Gradually each day the swelling increased in pain and size. Today is 10/15/2020 and the rash area is from just below my shoulder going down the top section of my arm  (1/2 the circumference of my upper arm) ending about 3" up from the bend of the elbow. Needle like pain in the rash area.  Going to walk in clinic to have it looked at and seek advice.
Age: 68.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Injection site joint discomfort, Joint stiffness
Clinical narrative: The patient called me on 10/15/2020.  She had to go to urgent care because she had an adverse reaction to the pneumovax immunization I gave her on 10/14/20.  She said she had joint stiffness on her right shoulder (I gave her the pneumovax shot in her right deltoid and her flu shot in her left deltoid).
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling of lips and eyes, patient took Benadryl, swelling has stopped
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Electrocardiogram, Seizure
Clinical narrative: Pt reports having a seizure for the first time in her life
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: 102.9 fever, body/muscle aches, fatigue
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Cerebrovascular accident, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had localized redness, swelling, soreness to injection, low grade fever day of injection then on Sunday develop s/s of stroke, seizure acitivity, aphasia, Todds Paralysis
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Postictal paralysis, Pyrexia, Seizure
Clinical narrative: Pt had localized redness, swelling, soreness to injection, low grade fever day of injection then on Sunday develop s/s of stroke, seizure acitivity, aphasia, Todds Paralysis
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Vaccination error
Clinical narrative: Influenza vaccination administration to an unintended patient (patient did not request influenza vaccination). She only requested Shingrix administration, but both were given.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered to patient on 10/7/2020; This spontaneous report has been received from a registered nurse referring to a 13 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.     On 07-OCT-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729, expiration date 01-DEC-2021; strength and route unknown) ; unspecified dose in series for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was above 9 degrees Celsius (11.3 degrees Celsius) for a time frame of 55 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event was reported. No product quality complaint was reported. 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: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional adverse events reported; adult dose of Vaqta was given to patient when he was still 17 years old; This spontaneous report was received from an office manager, referring to a 17-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.      On 25-AUG-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA), lot number S017741, expiration date 26-AUG-2020, as prophylaxis; a few weeks prior to his 18th birthday (incorrect dose administered) (strength, exact dose, route of administration, and anatomical vaccination site were not provided). No additional adverse events, no product quality complaint (PQC) or product confusion were reported. The outcome of incorrect dose administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017741; expirationdate: 26-AUG-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: FLU4, FLU4, FLUR4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: a 15 patients was vaccinated with flu vaccines via subcutaneously instead of intramuscularly using 5/8 inches needle, No AE; a 15 patients was vaccinated with flu vaccines via subcutaneously instead of intramuscularly using 5/8 inches needle, No AE; Initial information received on 21-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist.  This case is linked to 2020SA259700 (female patient case, same reporter).  This case involves a 15 patients (unknown demographics) who was vaccinated subcutaneously instead of intramuscularly using 5/8 inches needle with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number UJ467AB and expiry date 30-Jun-2021) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date (batch number and expiry date not reported) at an unknown administration site for prophylactic vaccination (incorrect route of product administration) (wrong device used).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate route of vaccination and wrong device used (latency: same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number of FLUBLOK QIV  and FLUZONE QUADRIVALENT for this case.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Symptom was a large 3-4 inch pink skin splotch and whelt (slightly defined swelling) at the injection site on the upper arm near shoulder. The whelt went away after one day but the pink splotch did not.  The unusual thing not experienced with the regular dose was that this pink discoloration migrated gradually down my arm close the elbow crook inner arm for four days then dissipated in color until  only traces remain after 5 days. I only had mild fatigue and some nausea. My arm and shoulder to the elbow was remarkably sore for five days.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Symptom was a large 3-4 inch pink skin splotch and whelt (slightly defined swelling) at the injection site on the upper arm near shoulder. The whelt went away after one day but the pink splotch did not.  The unusual thing not experienced with the regular dose was that this pink discoloration migrated gradually down my arm close the elbow crook inner arm for four days then dissipated in color until  only traces remain after 5 days. I only had mild fatigue and some nausea. My arm and shoulder to the elbow was remarkably sore for five days.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Face oedema, Injection site erythema, Muscle tightness
Clinical narrative: Reaction started with red spot on left upper arm 2 hours post injection and progressed to a large red area on left upper arm lateral and distal to injection site. Swelling increased over the couse of 2 days. By 10/15/2020 left hand and left side of face has pitting edema and the patient complains of neck tightness, a mild cough, and regurgitation.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Regurgitation, Swelling
Clinical narrative: Reaction started with red spot on left upper arm 2 hours post injection and progressed to a large red area on left upper arm lateral and distal to injection site. Swelling increased over the couse of 2 days. By 10/15/2020 left hand and left side of face has pitting edema and the patient complains of neck tightness, a mild cough, and regurgitation.
Age: 83.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Death, Mechanical ventilation
Clinical narrative: Wife called us on 10/15 to inform that patient did not do well after the vaccines. He was on ventilator for 5 days, then passed away.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Joint swelling, Local reaction, Swelling
Clinical narrative: Patient came in on 10/15/20 and reported localized swelling that traveled to elbow.  She also had redness around injection sight.  She did not use anything to treat it.  The swelling decreased over time and was cleared up in 48 hours.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Face oedema, Malaise, Myalgia, Pain
Clinical narrative: Hives to both arms and hands, edema (facial), increased respiratory rate, fever, chills, muscle aches and pains, malaise, localized pain
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory rate increased, Urticaria
Clinical narrative: Hives to both arms and hands, edema (facial), increased respiratory rate, fever, chills, muscle aches and pains, malaise, localized pain
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: N/A Patient was given regular flu dose instead of high-dose
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Deafness, Sudden hearing loss, Tinnitus
Clinical narrative: Sudden profound hearing loss with tinnitus.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Diplopia, Dizziness, Imaging procedure
Clinical narrative: Ataxia, Dizziness, Diplopia.  Diagnosed with ADEM.  Currently recovering on steroids, pending neuroimmunology evaluation
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Intensive care, Laboratory test
Clinical narrative: Ataxia, Dizziness, Diplopia.  Diagnosed with ADEM.  Currently recovering on steroids, pending neuroimmunology evaluation
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Left upper arm pain lasting for two weeks.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Hot flush, Pain
Clinical narrative: Next day she had severe fatigue, hot flashes, headaches, body aches, and 3 diarrhea stools. Denies ever having a fever. (However she takes meloxicam daily due to residual dyspnea and pleuritic pain s/p covid infection )
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Rashes, constant itchy skin
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Nausea, Nightmare
Clinical narrative: I have never had a reaction to any drug or injection.   I had the shot around 10:00 a.m. and started taking Advil immediately when I got home.  10 hours after this shot, I began to feel weak, sore all over and a little nauseous.  It came on quickly and only intensified.   I also had a loud ringing in my ears.  About 1/2 hour later, I began shaking uncontrollably.  I went to bed immediately and continued to shake in bed for 5 minutes.  My sleep was fitful with many nightmares.  The next day I still felt weak and  sore and had a headache with ringing in my ears.   It has now been over 48 hours and I till have body aches, possibly from all the shivering and shaking.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Tinnitus, Tremor
Clinical narrative: I have never had a reaction to any drug or injection.   I had the shot around 10:00 a.m. and started taking Advil immediately when I got home.  10 hours after this shot, I began to feel weak, sore all over and a little nauseous.  It came on quickly and only intensified.   I also had a loud ringing in my ears.  About 1/2 hour later, I began shaking uncontrollably.  I went to bed immediately and continued to shake in bed for 5 minutes.  My sleep was fitful with many nightmares.  The next day I still felt weak and  sore and had a headache with ringing in my ears.   It has now been over 48 hours and I till have body aches, possibly from all the shivering and shaking.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain
Clinical narrative: patient has had pain for 10 days at injection site and radiating around her back shoulder med
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 14OCT2020, 1800 - patient noted golf ball sized reddened, sore, swollen area on her left deltoid at the injection site. 15OCT2020, 1400 - Physician Assistant's evaluation: 7cm by 9 cm erythema, slightly swollen, warm to the touch and described by the patient as remaining sore.   B/P 142/67, Pulse 63, Temp: 96.7 F.   Rx for Prednisone 20mg #10, Two QD for 5 days.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Coordination abnormal, Dizziness, Gait disturbance
Clinical narrative: Two hours after receiving the influenza vaccine in my left arm, I was walking my dog at our usual fast pace along a familiar route, and suddenly became uncoordinated and giddy.  I had considerable difficulty directing my walk in the desired direction.  This lasted one or two minutes, when I recovered and was ably to complete the walk without falling over or being pulled over by my dog.  I had been walking for 35 minutes without any difficulty before the event occurred.  This was the first and only occasion that I had experienced symptoms of uncoordinated movement.  Also, the vaccination was the first I had been given in the past 61 years.  I did not experience any nausea.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Peripheral swelling
Clinical narrative: after given vaccine she woke started feeling itchy around the area where varicella was administered, then the next morning when she woke up she started to notice her arm swelling.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diarrhoea, Emotional distress, Vomiting
Clinical narrative: Diarrhea, vomiting, inconsolable crying; taken to urgent care for physical exam
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Patient experienced chills, nausea, vomiting, dizziness and headache.  These symptoms started the following morning after the administration and lasted for a couple of days.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Cough, Dizziness, Dysphonia
Clinical narrative: On Wednesday afternoon, started with a dry cough, hoarseness, chills, sore throat,  no fever.  Had chills the next day but no fever. called the clinic was tested for COVID-19, results came back negative.  On Friday, had weakness and difficulty breathing.  Also had some dizziness and weakness until today which she is doing fine.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: On Wednesday afternoon, started with a dry cough, hoarseness, chills, sore throat,  no fever.  Had chills the next day but no fever. called the clinic was tested for COVID-19, results came back negative.  On Friday, had weakness and difficulty breathing.  Also had some dizziness and weakness until today which she is doing fine.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Fatigue, Feeling hot, Headache, Injection site erythema
Clinical narrative: within 20min post injection student c/o itchiness, hot to the touch and redness at injection; hydrocortisone cream and ice pack applied; 2 hours post injection starting having headaches, fatigue, malaise, decreased appetite, nausea which all lasted until 10/7 am; on 10/7 am body started feeling hot , still had headache and fatigue
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site warmth, Malaise, Nausea
Clinical narrative: within 20min post injection student c/o itchiness, hot to the touch and redness at injection; hydrocortisone cream and ice pack applied; 2 hours post injection starting having headaches, fatigue, malaise, decreased appetite, nausea which all lasted until 10/7 am; on 10/7 am body started feeling hot , still had headache and fatigue
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: prolonged l arm/shoulder pain x 2 weeks
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Urticaria
Clinical narrative: Hives/ Whelps all over body Redness  Skin warmth Intense itching/ pain
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Scab
Clinical narrative: painful shingles like rash on R arm blisted then scabbed responded to valtrex
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Bronchial irritation, Diarrhoea, Emotional distress, Fatigue
Clinical narrative: PCP gave her the flu shot on 10/12/20 at 3pm. About 3:30 that day, she felt emotional distress with anxiety, which is atypical for her. That evening around 6-7pm, she felt "off" with fatigue and the sense that something is wrong. she felt an irregular heat beat (this had happend to her one other time while healing from Covid).  She felt bronchial irritation, mild headache, brain fog, one loose stool, mild nausea. These symptoms resolved the afternoon of 10/13/20.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache, Heart rate irregular, Nausea
Clinical narrative: PCP gave her the flu shot on 10/12/20 at 3pm. About 3:30 that day, she felt emotional distress with anxiety, which is atypical for her. That evening around 6-7pm, she felt "off" with fatigue and the sense that something is wrong. she felt an irregular heat beat (this had happend to her one other time while healing from Covid).  She felt bronchial irritation, mild headache, brain fog, one loose stool, mild nausea. These symptoms resolved the afternoon of 10/13/20.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: 12x15 cm erythematous lesion of L arm. Mildly a=swollen and warm to touch.No edema
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Urticaria
Clinical narrative: Developed hives on the legs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: CELLULITIS LIKE REACTION, "SIZE OF BASEBALL" PCP LOOKED AT AND NO DIAGNOSIS WAS GIVEN
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: I know it was the quad, but not sure which one.  I had an extreme fever, 103-104, headache, aches, rapid heart beat.  this lasted for 48 hours, i did have times with no fever, was using tylenol and advil along with cold compresses to reduce the fever.  I woke up this am feeling much better.  Hopefully it is over.  I wanted to report this because of the covid and pneumonia tie in.  If i can be of any help to you please don't hesitate to call or email.