chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Injection site haemorrhage
Clinical narrative: when the needle was removed, the injection site bled.; when the needle was removed, the injection site bled.; when the needle was removed, the injection site bled./hard to determine if the patient got a full dose; injection site bled; This case was reported by a other health professional via call center representative and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th August 2019).   On 14th January 2020, the patient received the 2nd dose of Shingrix. On 14th January 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage, inadvertent exposure to vaccine, accidental underdose and exposure via skin contact. On an unknown date, the outcome of the injection site hemorrhage, inadvertent exposure to vaccine, accidental underdose and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The Other health professional reported that a patient got first dose of Shingrix on 27th August 2019 The patient got the second dose on 14th January 2020. However, when the needle was removed, the injection site bleed. It was hard to determine if the patient got a full dose or not. The HCP was considering giving a 3rd dose or re-starting the complete series. This led to product administration error, accidental underdose and exposure via skin contact. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and heat at injection site; Redness, and heat at injection site; Heat at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling, redness, and heat at injection site following a dose of Shingrix.  The reporter consented to follow up.  The events lasted for 4-5 days following administration. No additional information provided. The case has been linked with the case US2020AMR163530, reported as same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163530:several other patients case US-GLAXOSMITHKLINE-US2020161260:same reporter
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy within 24h after receiving the first dose on 06Mar2020; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The patient did not want to receive 2nd dose because experienced Bell's palsy after receiving the first dose.  The follow up consent was granted.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: Full body aches; Fatigue; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for two patients. This is first of two reports.   A 16-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 24 hours after the vaccination, the patient experienced full body aches and fatigue. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020322824 Same reporter, product, AE and different patient
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: full body aches; fatigue; This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for two patients. This is second of two reports.   A 16-years-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 24 hours after the vaccination, the patient experienced full body aches and fatigue. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020322822 same reporter, product, AE and different patient
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: After 5 days  the patients arm was still very red and swollen. It was also very hot to the touch and it was getting worse. Patient was not running a fever but the swelling and redness was getting worse, not better. There was also a bruise about 4 inches in diameter surrounding the area from the vaccine. She denied taking any blood thinners or aspirin daily. She took Tylenol and used warm compresses to help with the swelling. I advised the patient to follow up with primary MD. I also contacted her MD to inform them of the adverse reaction.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 17 year old patient was given was adult Hepatitis B instead of the pediatric dose .
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called in to request provider visit to discuss persistent left arm pain since receiving vaccination. Patient reported pain during activities of daily living.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Feeling abnormal, Headache, Insomnia
Clinical narrative: Patient reported the next day to the pharmacy to describe adverse event. She states about 1.5-2 hours after the shot she began to experience chest pain and tightness as well as her head feeling weird and headache. She states that she laid down and went to sleep. She reported having trouble sleeping but by the morning she was feeling completely normal. She came to the pharmacy at 2:30pm to report all this, I asked her how she was feeling today and she reported no lingering symptoms. She stated she just wanted to report the reaction but now she is fine but she was scared. I asked her if she has ever experienced a reaction to a vaccine before and she said no she gets a flu shot every year with no issue. I told her in the future if she were to experience chest pain, etc she should seek medical attention while it is happening instead of waiting until the next day. I asked when her next physician appointment is so that she can follow up and also report the reaction to them, she states she has an appointment made for 8/25/20.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored administered vaccines; This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On 05-AUG-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038175, expiration date 26-NOV-2021 (exact dose, route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) lot # S020160, expiration date 30-JUN-2021 (exact dose, route and site of administration were not reported) for prophylaxis. Administered doses of vaccines were exposured for the temperature excursion as follows:- 6 degrees Fahrenheit (F) to 14F (10F) for 1 hour and 15 minutes; 15F to 46F (44.8F) for 1 hour and 30 minutes; 47F to 77F (50F) for 2 hours and 30 minutes There was no previous temperature excursion. The call was because of a digital data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Ischaemic stroke, Visual field defect, Visual impairment
Clinical narrative: acute right arterial ischemic stroke; loss of left field vision; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 30-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered visual disturbances affecting the left side of both eyes. The patient was diagnosed with acute right arterial ischemic stroke and loss of left field vision. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events acute right arterial ischemic stroke and loss of left field vision was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events acute right arterial ischemic stroke and loss of left field vision to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 02-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: now has come down with shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and experienced shingles. The follow up consent was not granted.
Sex: U
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: seizure for about 10-15 seconds; Initial information received on 12-Aug-2020 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown demographic patient who experienced seizure, while received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination included FLUZONE QUADRIVALENT but she was not allergic to it. The patient's other medical history, past medical treatment, family history and concomitant medication were not provided.  On 12-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 12-Aug-2020, the patient developed a serious seizure one minute (also reported as within 30 seconds) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Details of laboratory data was not reported.  Final diagnosis was seizure.  It was not reported if the patient received any corrective treatment.  On 12-Aug-2020, the patient had recovered from the event (reported as lasted for 10-15 seconds).  Information on batch number is requested.; Sender's Comments: This case concerns an unknown demographic patient who experienced seizure one minute following the vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible for the role of vaccine. However, the patient's medical history, medical condition at the time of vaccination and laboratory data ruling out other etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: About 2 hours after the injection patient experience arm pain that led to such pain he was unable to move it. This resolved overnight and he is now only slightly tender 2 days later. About 4 hours after the injection patient experienced shortness of breath that persisted until he fell asleep that night. He states that he was unable to pull a full breath and was forced to lay prone with his feet elevated to even get a breath in.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Adverse reaction, Blister, Cellulitis, Erythema, Induration
Clinical narrative: Pt started having redness and warmth at injection site the morning after injection given, developed rapidly. seen in MD office 28 hours later -dx large local reaction. continued to worsen and went to ED 34 hours after. noticed some blistering/fluid filled lesions. redness spreading. no fever. dx with cellulitis and put on clindamycin. seen back in our office the next day after 2 days of clindamycin. continued to have increasing redness/induration. no fever still. dx with arthur reaction
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Pt started having redness and warmth at injection site the morning after injection given, developed rapidly. seen in MD office 28 hours later -dx large local reaction. continued to worsen and went to ED 34 hours after. noticed some blistering/fluid filled lesions. redness spreading. no fever. dx with cellulitis and put on clindamycin. seen back in our office the next day after 2 days of clindamycin. continued to have increasing redness/induration. no fever still. dx with arthur reaction
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Autoimmune disorder, Cognitive disorder, Computerised tomogram head, Fatigue, Inflammation
Clinical narrative: ASIA Syndrome with neurologic autoimmunity, cognitive changes, fatigue and acute inflammatory disorder
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Positron emission tomogram
Clinical narrative: ASIA Syndrome with neurologic autoimmunity, cognitive changes, fatigue and acute inflammatory disorder
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RA became red, swollen and warm to touch
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chills, Condition aggravated, Fatigue
Clinical narrative: Patient reports had adverse reaction to #1 RZV immunization.  Vax administered on 8/18/20.  States woke up 8/19/20 AM with worse than normal low back pain, fatigue, chills/shivers, T 100.2, nausea. headache.  States took Tylenol and rested all day.  Temp down to 99.2 by afternoon, slept well last NOC, and woke up this AM asymptomatic.  States he discussed with his PCP and has decided he does not want #2 RZV.  Did have HZV in 2014.  Verbal permission to report to VAERS received.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Patient reports had adverse reaction to #1 RZV immunization.  Vax administered on 8/18/20.  States woke up 8/19/20 AM with worse than normal low back pain, fatigue, chills/shivers, T 100.2, nausea. headache.  States took Tylenol and rested all day.  Temp down to 99.2 by afternoon, slept well last NOC, and woke up this AM asymptomatic.  States he discussed with his PCP and has decided he does not want #2 RZV.  Did have HZV in 2014.  Verbal permission to report to VAERS received.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Mouth ulceration
Clinical narrative: Oral ulcers in hard palate in mouth behind teeth. Dr. was not sure what to do for it. Doesn't hurt as bad as it did 2-3 days ago.  Took homeopathic remedy for shingles within 2 or days, they were gone.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Felt Soreness Redness Swelling
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: yesterday mom reports patient has large welt, redness, and warm swelling to L) arm
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Limb discomfort, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pt reports that he started having swelling and redness in his arm. It extended to his shoulder and armpits. It feels heavy and he has pain with lifting .
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Pt reports that he started having swelling and redness in his arm. It extended to his shoulder and armpits. It feels heavy and he has pain with lifting .
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysphonia, Pyrexia, Urticaria
Clinical narrative: Patient presents to clinic on 8-20-2020 due to adverse reaction to recent Shingrix vaccine. She received the vaccine at 0930  on 8-17-2020 in her right deltoid. No immediate reaction observed. On the evening of 8-17-2020 patient does report feeling feverish and having chills. On 8-18-2020 she does not report any symptoms. On 8-19-2020 she reports hives all over body but her thighs and raspy/hoarse voice. She denies swelling of throat or face. Denies fevers.  Treatment to be completed at patient home after medication picked up from pharmacy. Medications ordered: Prednisone 20 mg BID x5 Benadryl: 25 mg 1-2 every 6 to 8 hours Patient is discharged from clinic. Outcome unknown and it is too early to determine. Will follow-up with patient on 8-21-2020.
Age: 13.0
Sex: F
Vaccine: HPV9, IPV
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out on exam table. No injury. Woke with smelling salts. BP 107/68
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Within hours of the vaccine injection, I experienced soreness and swelling of the upper arm and a rash that appeared halfway up the upper arm and that slowly migrated to the inner , elbow-region, of the left arm.  The soreness and edema persisted for 4 days.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: C/o neck pain and stiffness 3 hours after vaccine. Mother gave child aleve and felt that he was improving. Suggested that possible urgent care or ER visit or doctor visit may be warranted if not improving.
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Hyperhidrosis, Muscle spasms, Muscle tightness
Clinical narrative: MUSCLE TIGHTNESS, CRAMPING FROM JAW DOWN TO BREAST (ON LEFT SIDE ONLY), SWEATING. BEGAN APPROXIMATELY 15 MINUTES POST-VACCINATION AND LAST FOR 4-5 MINUTES. PATIENT SAYS SHE HAS THIS REACTION ON OCCASION, UNRELATED TO VACCINES.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Feeling hot, Hypoaesthesia, Lung disorder
Clinical narrative: 30 SECS: HEAVINESS IN LUNGS, REDNESS IN FACE AND HOT/SWELLING FEELING 2 MINS: MOVED FROM FACE TO LOWER BACK WITH MUSCLES SPAMS AND FEELING OF EXTREME DISCOMFORT - FACE DID COME BACK TO REGULAR COLOR 4MINS: LEGS AND ARMS HAD A TINGLING/NUMBNESS FEELING  THAT LASTED FROM ABOUT 5 MINS - NO DIZZINESS - WAS ABLE TO STAND AFTER BACK SPASMS AFTER 10 MINS WAS BACK TO NORMAL WITH NO SIDE EFFECTS OCCURING
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Paraesthesia, Swelling
Clinical narrative: 30 SECS: HEAVINESS IN LUNGS, REDNESS IN FACE AND HOT/SWELLING FEELING 2 MINS: MOVED FROM FACE TO LOWER BACK WITH MUSCLES SPAMS AND FEELING OF EXTREME DISCOMFORT - FACE DID COME BACK TO REGULAR COLOR 4MINS: LEGS AND ARMS HAD A TINGLING/NUMBNESS FEELING  THAT LASTED FROM ABOUT 5 MINS - NO DIZZINESS - WAS ABLE TO STAND AFTER BACK SPASMS AFTER 10 MINS WAS BACK TO NORMAL WITH NO SIDE EFFECTS OCCURING
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient's arm has extreme pain and soreness. Patient is unable to lift her left arm above her head. This has been ongoing for 8 days. Patient will be seeing her physician very soon.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient had redness and swelling at injection site, and patient began to have a fever, chills, and body aches approximately 4 hours after vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPE AFTER VACCINCE
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: febrile seizure of approx 2 minutes no previous history.  ER visit but not admitted.  Still having intermittent fevers but below 101.5 today
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Syncope
Clinical narrative: was given a Tdap shot in the vaccine room at  pharmacy. Pt did not present any symptoms at the time of the shot. After the shot, once pt got up and started walking, she initially felt okay, but as she continued walking she told her mother she started to feel dizzy. At the point her mother believes she fainted. Her mother was able to guide her to the floor without injury. At this point another shopper came back to the pharmacy to let the pharmacist know someone needed assistance. I came out and realized it was the same patient I had administered the Boostrix shot to.  was sitting up on the ground. She was awake and responsive but still felt dizzy.  She was given a cup of water to drink and her blood pressure was checked. Her BP was 103/68 and pulse was 66. She said she had eaten breakfast but not lunch. Her mother noted that she is not used to wearing a mask and thought maybe that could have added to the adverse reaction. After sitting on the ground for a few minutes, pt was able to transfer to a wheelchair and was escorted out of . At that time she was given a water bottle, trail mix and fruit roll up. I followed up with her mother the following day,  and she said  had fully recovered in about 2  hours and woke up feeling "back to normal" this morning, with just some expected pain at the area of injection.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash all over body no other sx.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Loss of personal independence in daily activities, Lymph node pain
Clinical narrative: Patient reported on next morning (8/19/20) after administration that he thought he was having an adverse reaction to the vaccines as he had fever, chills, body aches, fatigue and his right arm hurt (including around the arm -trap area, armpit)-he described pain around lymphnodes. His temp was measured again and it was 98.6. He went home sick from work. His spouse then called on 8/20/20 & indicated that he had been alternating w/tylenol/advil to keep fever down but it kept going up to 102-103 degrees using ear thermometer (she questioned the accuracy of the thermometer). I advised  to call MD and test for COVID-referred them to Urgent Care. He asked for records to be sent to md-resent them this time via fax on 8/20/20.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reported on next morning (8/19/20) after administration that he thought he was having an adverse reaction to the vaccines as he had fever, chills, body aches, fatigue and his right arm hurt (including around the arm -trap area, armpit)-he described pain around lymphnodes. His temp was measured again and it was 98.6. He went home sick from work. His spouse then called on 8/20/20 & indicated that he had been alternating w/tylenol/advil to keep fever down but it kept going up to 102-103 degrees using ear thermometer (she questioned the accuracy of the thermometer). I advised  to call MD and test for COVID-referred them to Urgent Care. He asked for records to be sent to md-resent them this time via fax on 8/20/20.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Syncope
Clinical narrative: Syncope (likely vasovagal), recovered in <5 min to baseline. Was given Gatorade and crackers and vital signs were monitored.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient experienced itching at injection site about 20 minutes after vaccination. About 1 hour after vaccine he experienced hives. Has never had an allergic reaction to flu shot before. Patient took two Benadryl and symptoms resolved
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase, Injection site pain, Muscular weakness, Myoglobin blood, Pain
Clinical narrative: Injection site was sore the first week. Starting the second week, upper arm became more sore, and pain extended down biceps to elbow. She has pain when lifting or using that arm and it feels weaker. It is still hurting just as severely as the 2nd week after the injection
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 100.1, chills, sore throat
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: The patient had redness at the injection site that was fairly large, maybe 2 inches around the injection site all around. It started after she received the vaccine. She came by the pharmacy to what she could do. I told her to take some Tylenol or Mortrin for the pain and to let us know if it got any worse.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called tonight to ask about his flu shot that he received on 8/11/20. He is reporting shoulder pain. Upon talking to him, he stated that when he got the shot it hurt but he did not say anything because it is a shot. His arm was sore (dull ache) for 3 days and then the pain went away. But 3 days ago, he states the pain came back and every time he lifts his arm, he has a sharp pain in his shoulder. He did have a slight fever the next day after the shot. He was also very familiar with the terminology of SIRVA. I asked him multiple times about the dull pain going away and he said yes. The sharp pain did not start until 3 days ago (8/17/20). I also referred him to see a doctor and he is seeing one tomorrow.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient indicates little soreness next day after injection on 8/12/2020. On 8/13/2020, patient woke up to redness/swelling/pain/warm to touch area around injection site approx 3-4 inch diameter. Patient concerned because no previous reaction to a flu shot and went to urgent care for assessment. Patient received rx for Keflex 500mg BID x 7 days.
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood glucose, Cold sweat, Dizziness, Heart rate decreased, Syncope
Clinical narrative: Syncope - onset less than 1 minute - Patient was lightheaded/dizzy, cold sweat, felt clammy, slow pulse rate  Pharmacist instructed patient to remain seated. Pharmacist monitored symptoms and checked pulse. Patient gradually recovered over 5 minute period. Patient asked EMS to evaluate her. EMS evaluated her and cleared her to leave when symptoms resolved.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Nausea, Paraesthesia
Clinical narrative: Patient reported some nausea the next day and pain in her shoulder. On 8/14/20 she received a 5 day course of prednisone. She said there had been some improvement but on 8/20/20 it seems to be worse. She has limited movement of her shoulder and some tingling in her arm. She will continue to seek medical treatment.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: pt noted that he stated experiencing red spots all over his arms, legs, and trunk the evening following the vaccination with no other changes to his regimen or activities. Pt reports mild itchiness.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Severe body aches, high fever upto 103 degree, chills, joint pain, dizziness
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Severe body aches, high fever upto 103 degree, chills, joint pain, dizziness
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Patient received vaccination in the afternoon of 08/19, she reported to the pharmacy on 08/20 with significant erythema and a small amount of heat to the area. The erythema extended from shoulder to elbow area. Patient did not report any pain, but did have mild soreness around the injection site.  Spoke with the patient several hours later and erythema/pain did not increase.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt is experiencing swelling, redness and itchiness on left arm about 1 inch below injection site. Rph instructed pt to ice the area that is affected and take benadryl at bedtime to reduce symptoms. Pt will also call primary care provider in the AM if symptoms are still present.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pruritus, Pyrexia, Skin warm
Clinical narrative: Patient stated that on 08/05/2020 in the morning they experienced nausea/ fever which lasted until 08/07/2020.  starting 08/07/2020 patient stated that their left arm got "hot to the touch" , started itching, and was red.  Patient reported that the itching spread to her whole body starting 08/11/2020 and has persisted and not diminished.  Patient stopped by the pharmacy 08/20/2020 at 6 pm and reported the side-effects to the pharmacist on duty.  Patient was counseled to seek immediate medical attention which the patient stated that they did not want to go see a doctor they would just buy Benadryl.  Patient bought Benadryl and left the store after repeatedly being told to seek immediate medical attention.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: BLEEDING AT INJECTION SITE (BLOOD ON BANDAID) BRUISING AND THE SHOT HURT
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Erythema of eyelid, Pruritus, Urticaria
Clinical narrative: eyelid red and whelps rt eye, Then, under breast and on, side of face, ear, neck, shoulder, chin, under and on,  nose - tip of & under & hands  very itchy & red mostly on right side
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Slow response to stimuli, Tremor, Unresponsive to stimuli
Clinical narrative: When administering the vaccines - she slumped back and her upper body started to shake for about 5 seconds. She did not respond for a few seconds and then was very slow to respond.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, pain and itching 3.5 x 3.5 irregular area. Minimal swelling.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: red area of injection
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Respiratory arrest
Clinical narrative: 2 days after receiving 4 month vaccines she stopped breathing. Needed emergency care. Mom deferred further vaccines
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Syncope, Vomiting
Clinical narrative: pt stated had gotten faint after flu shot couple years ago but was fine last year. Gave flu shot & insisted her to stay in store for 10-15 minutes. Manager spotted her on cameras from office going down at front register. went up, gave her chair to sit in, small sip of water. she has peaked but said her vision was better. suddenly she said she felt sick & started vomiting, vomited 2-3 times but said she felt better. suddenly got ash white & was not responding to my gestures.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Began having Swelling, pain w/moving Rt arm after shot on 8/18/20 - Redness around the shot (injection Site) 1.5 inches x 1.75 inches in diameter. Tender. Full ROM in shoulder, but pain w/ movement. Seen on 8/20/20.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Inflammation, Pruritus, Rash
Clinical narrative: The rash began with a red and inflamed bump on my arm. The bump became to be really itchy and even more inflamed. I have had the bump for about two days now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine rxn x2d. Warm to touch swollen (R) leg  Dx: (R) thigh cellulitis give Benadryl & Motrin in 8 hrs. keep leg up,  Apply ice pack.
Age: 74.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt reported on 8/20/2020 as his upper arm and lower arm was swollen & warm on 8/18/20. On 8/20/20 upper arm is better, but lower arm is still little swollen, getting better. slowly recovering.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, HPV9, MNQ, UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Product Lot number issue; did not have any reactions/date and time adverse event started: 11-JUN-2029; Information has been received from a healthcare professional on request by the Company from the FDA under the Freedom of Information Act (VAERS # 819098-1) on 14-JUL-2020, and refers to a male patient of unknown age. The patient had no known drug allergies. His concurrent conditions, medical history and concomitant medications were not provided.  On 20-JAN-2019 at 14:00, at the age of 15 years old, the patient was administered the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscularly in left arm (dose was not provided) for prophylaxis. Reporter reported quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with lot# R024271, expiry date not provided but upon internal validation established as 08-MAY-2021, which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). However, lot# R024271 was valid for human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same date at 14:00, the patient received also the second dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in right arm, lot# S001832, expiry date not provided but upon internal validation established as 12-MAY-2020 (dose was not reported) and the third dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), intramuscularly in left arm, lot# U62004aa (dose and expiry date were not provided), both for prophylaxis.   It was reported that the onset date of the event was on 11-JUN-2019 (adverse event), however it was also reported that the patient did not have any reactions (conflicting information)  The outcome of the event was reported as recovered.   The causal relationship between the event and the suspect vaccine was not provided by the reporter.   Follow-up information has been received from the registered nurse on 04-AUG-2020.  The patient information was updated. It was reported that the date of vaccination was on 11-JUN-2019 (previously reported as 20-JAN-2019). The nurse stated that the patient received multiple vaccines on the same date, and it was given an extra dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), but he did not experience any adverse reaction (conflicting information).     The nurse considered that the event was not related to the suspect vaccines.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: Antifa lactic.  Sudden on set dizzy, shortness of breath, rapid heart beat, nausea vomiting, muscle ache legs and arms, tightness in throat
Age: 71.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Palpitations, Vertigo
Clinical narrative: Antifa lactic.  Sudden on set dizzy, shortness of breath, rapid heart beat, nausea vomiting, muscle ache legs and arms, tightness in throat
Age: 71.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Myalgia, Nausea
Clinical narrative: Antifa lactic.  Sudden on set dizzy, shortness of breath, rapid heart beat, nausea vomiting, muscle ache legs and arms, tightness in throat
Age: 71.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Throat tightness, Vomiting
Clinical narrative: Antifa lactic.  Sudden on set dizzy, shortness of breath, rapid heart beat, nausea vomiting, muscle ache legs and arms, tightness in throat
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Disorientation, Disturbance in attention, Fatigue
Clinical narrative: began with site pain, redness and swelling turning to hard lump 4 inch circular and 1/2 inch protruding in 4 hours - headache and light perspiration in 5 hours - exhaustion, intestinal distress and light vertigo in 7 hours - disoriented in 8 hours, losing track of activity and thoughts - difficulty sleeping for arm pain with added joint pain - next morning all same symptoms with increase disorientation and unable to drive, cook, do most tasks with little recall of full day or night - better sleep second night - next day less headache, no intestinal distress, less arm pain and swelling, no joint pain but unable to focus or recall most of activities in day - third night sound sleep - next day  much improved arm but new itching sensation that worsened, better mental ability but remained exhausted - fourth night difficult sleep with injection site itching but less swelling - next morning decreased itching, better mental and energy returned - foggy mind continued two more days while all pain subsided and itching gone by 6th day - bump remains at injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Impaired driving ability, Injection site erythema, Injection site mass
Clinical narrative: began with site pain, redness and swelling turning to hard lump 4 inch circular and 1/2 inch protruding in 4 hours - headache and light perspiration in 5 hours - exhaustion, intestinal distress and light vertigo in 7 hours - disoriented in 8 hours, losing track of activity and thoughts - difficulty sleeping for arm pain with added joint pain - next morning all same symptoms with increase disorientation and unable to drive, cook, do most tasks with little recall of full day or night - better sleep second night - next day less headache, no intestinal distress, less arm pain and swelling, no joint pain but unable to focus or recall most of activities in day - third night sound sleep - next day  much improved arm but new itching sensation that worsened, better mental ability but remained exhausted - fourth night difficult sleep with injection site itching but less swelling - next morning decreased itching, better mental and energy returned - foggy mind continued two more days while all pain subsided and itching gone by 6th day - bump remains at injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: began with site pain, redness and swelling turning to hard lump 4 inch circular and 1/2 inch protruding in 4 hours - headache and light perspiration in 5 hours - exhaustion, intestinal distress and light vertigo in 7 hours - disoriented in 8 hours, losing track of activity and thoughts - difficulty sleeping for arm pain with added joint pain - next morning all same symptoms with increase disorientation and unable to drive, cook, do most tasks with little recall of full day or night - better sleep second night - next day less headache, no intestinal distress, less arm pain and swelling, no joint pain but unable to focus or recall most of activities in day - third night sound sleep - next day  much improved arm but new itching sensation that worsened, better mental ability but remained exhausted - fourth night difficult sleep with injection site itching but less swelling - next morning decreased itching, better mental and energy returned - foggy mind continued two more days while all pain subsided and itching gone by 6th day - bump remains at injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vertigo
Clinical narrative: began with site pain, redness and swelling turning to hard lump 4 inch circular and 1/2 inch protruding in 4 hours - headache and light perspiration in 5 hours - exhaustion, intestinal distress and light vertigo in 7 hours - disoriented in 8 hours, losing track of activity and thoughts - difficulty sleeping for arm pain with added joint pain - next morning all same symptoms with increase disorientation and unable to drive, cook, do most tasks with little recall of full day or night - better sleep second night - next day less headache, no intestinal distress, less arm pain and swelling, no joint pain but unable to focus or recall most of activities in day - third night sound sleep - next day  much improved arm but new itching sensation that worsened, better mental ability but remained exhausted - fourth night difficult sleep with injection site itching but less swelling - next morning decreased itching, better mental and energy returned - foggy mind continued two more days while all pain subsided and itching gone by 6th day - bump remains at injection site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cellulitis, Erythema, Fatigue, Induration
Clinical narrative: shot hurt when given unlike any other vaccine I have received About 3 hours after shot, my arm got really red, swollen, hard, and warm to the touch  It almost looks like I have Cellulitis and may have to go to Urgent Care Arm is very sore  I am very tired and achy and have very little energy after the shot This hurts worse than a tetnus shot
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: shot hurt when given unlike any other vaccine I have received About 3 hours after shot, my arm got really red, swollen, hard, and warm to the touch  It almost looks like I have Cellulitis and may have to go to Urgent Care Arm is very sore  I am very tired and achy and have very little energy after the shot This hurts worse than a tetnus shot
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, nauseous, headache, slight fever 99.8, and chills
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Nausea
Clinical narrative: difficulty breathing headache body aches nausea chills and sweats sleepy
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Somnolence
Clinical narrative: difficulty breathing headache body aches nausea chills and sweats sleepy
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria
Clinical narrative: hives within days at injection site then systematically [...] without anaphylaxis; Information has been received from the Food and Drug Administration (FDA) AGENCY (Agency Control # 6230318) on 12-MAY-2020.  This spontaneous report as received from an other health professional refers to a 12-year-old female patient.    On 21-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: vial, lot # R026716, expiration date was not reported but upon internal validation established as 30-MAY-2021, intramuscularly in the left deltoid for prophylaxis. On 23-MAY-2019, 1 day 9 hrs 47 min after onset of therapy the patient experienced hives at injection site without anaphylaxis. The outcome of infusion site urticaria was reported as recovered/resolved.  The relatedness between the event and the suspect vaccine was not reported.  Follow-up information has been received from a physician on 17-AUG-2020. The reporter stated that the patient in this report was not seen in the physician's office (wrong office).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; PROQUAD was administered on 8/3/2020 but expired on 8/2/2020; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 03-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliters as prophylaxis (ml) (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number S003326, expiration date reported 02-AUG-2020, which were verified to be valid). There was no previous temperature excursion. No additional events were reported.