chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Achy like someone  stepped on her; Redness at the injection site; Swelling at the injection site; Intense itching where the swelling is; Muscles felt achy; Heat/ felt feverish; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced pain, injection site erythema, injection site swelling, injection site itching, myalgia and feeling hot. The patient was treated with PARACETAMOL (TYLENOL). On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site itching was resolved with sequelae and the outcome of the myalgia and feeling hot were unknown.   It was unknown if the reporter considered the pain, injection site erythema, injection site swelling, injection site itching, myalgia and feeling hot to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and felt feverish and achy like someone stepped on her. She had redness and swelling at the injection site, which she treated with a warm soaks. She also stated that she had intense itching where the swelling was on her arm. The itching was resolved but the redness and swelling were still there although they were improved. The patient still felt like someone stepped on her at time of reporting and took Tylenol to relieve the symptoms. She also stated that her muscles felt achy. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: Rash/ red marks on his lower right back; pain in his left arm that affected his ability to lay down and sleep last night; Pain in the arm; Pain in the arm that was injected, and spread to the shoulder; weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th October 2019).   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2020, 2 hrs after receiving Shingrix, the patient experienced pain in arm, shoulder pain and weakness. On 29th January 2020, the patient experienced sleep disturbance. On 30th January 2020, the patient experienced rash. The patient was treated with hydrocortisone (Cortizone Cream). On an unknown date, the outcome of the pain in arm, shoulder pain and weakness were not recovered/not resolved and the outcome of the sleep disturbance and rash were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, weakness, sleep disturbance and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine and about 2 hours later, the patient reported pain in the arm that was injected and spread to the shoulder. The patient also experienced weakness. The patient went to urgent care and was discharged with advice to place heat on the injection site. The patient had excruciating (severe) pain in his left arm that affected his ability to lay down and sleep at night. The patient also had red marks on his lower right back also described as a rash and recommended to use Cortizone cream. The emergency room visit was required for patient. The reporter did not consent to follow up
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Rash/ red marks on his lower right back; pain in his left arm that affected his ability to lay down and sleep last night; Pain in the arm; Pain in the arm that was injected, and spread to the shoulder; weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th October 2019).   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2020, 2 hrs after receiving Shingrix, the patient experienced pain in arm, shoulder pain and weakness. On 29th January 2020, the patient experienced sleep disturbance. On 30th January 2020, the patient experienced rash. The patient was treated with hydrocortisone (Cortizone Cream). On an unknown date, the outcome of the pain in arm, shoulder pain and weakness were not recovered/not resolved and the outcome of the sleep disturbance and rash were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, weakness, sleep disturbance and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine and about 2 hours later, the patient reported pain in the arm that was injected and spread to the shoulder. The patient also experienced weakness. The patient went to urgent care and was discharged with advice to place heat on the injection site. The patient had excruciating (severe) pain in his left arm that affected his ability to lay down and sleep at night. The patient also had red marks on his lower right back also described as a rash and recommended to use Cortizone cream. The emergency room visit was required for patient. The reporter did not consent to follow up
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest discomfort, Gait inability, Injection site erythema, Joint injury
Clinical narrative: torn MCL; her knee was very painful; often difficult to walk / unable to bear her full weight on her knee; chest congestion; difficult for her to raise; arm was very sore; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2019, less than 5 months after receiving Shingrix, the patient experienced pain and injection site erythema. On an unknown date, the patient experienced ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased. On an unknown date, the outcome of the pain, injection site erythema, ligament tear, knee pain and unable to walk were recovered/resolved and the outcome of the chest discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the pain, injection site erythema, ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received the first dose of Shingrix intramuscularly. The patient's injection itself did not hurt at all, but shortly after her arm was very sore, it also became very red at the injection site. The symptoms lasted about 1 week and her arm was sore enough it was difficult for her to raise it. About 1 month after the injection she was running and suffered a knee injury.  The patient was diagnosed, without an magnetic resonance imaging, as a torn MCL. over the next several months her knee was very painful and it was often difficult to walk.  She was unable to bear her full weight on her knee and it felt very unstable. Due to continused knee problems, she had an appointment scheduled with the orthopedist on 16th January 2020. About 1 week prior to getting the second dose of Shingrix she developed some chest congestion, which she still had when she got the second dose. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in Argus. For tolerance of 2nd dose, refer case US2020AMR017267.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Ligament rupture, Mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: torn MCL; her knee was very painful; often difficult to walk / unable to bear her full weight on her knee; chest congestion; difficult for her to raise; arm was very sore; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2019, less than 5 months after receiving Shingrix, the patient experienced pain and injection site erythema. On an unknown date, the patient experienced ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased. On an unknown date, the outcome of the pain, injection site erythema, ligament tear, knee pain and unable to walk were recovered/resolved and the outcome of the chest discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the pain, injection site erythema, ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received the first dose of Shingrix intramuscularly. The patient's injection itself did not hurt at all, but shortly after her arm was very sore, it also became very red at the injection site. The symptoms lasted about 1 week and her arm was sore enough it was difficult for her to raise it. About 1 month after the injection she was running and suffered a knee injury.  The patient was diagnosed, without an magnetic resonance imaging, as a torn MCL. over the next several months her knee was very painful and it was often difficult to walk.  She was unable to bear her full weight on her knee and it felt very unstable. Due to continused knee problems, she had an appointment scheduled with the orthopedist on 16th January 2020. About 1 week prior to getting the second dose of Shingrix she developed some chest congestion, which she still had when she got the second dose. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in Argus. For tolerance of 2nd dose, refer case US2020AMR017267.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Last 2 years I received the pnuemonia vaccine and then got pneumonia twice; Last 2 years I received the pnuemonia vaccine and then got pneumonia twice; This is spontaneous report from a contactable consumer.   A (age 79, unit unknown) male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  In the last 2 years he received the pnuemonia vaccine on an unspecified date and then he got pneumonia twice on an unspecified date. Therefore, the patient did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months. The outcome of the event was of unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site cellulitis, Injection site pain, Pain, Pain of skin
Clinical narrative: Cellulitis at the injection site; Pain at the site; Achiness; Fever; Headache; Extreme effects were the tingling skin; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; This is a spontaneous report from a contactable consumer (mother) from a Pfizer sponsored program.   A 16-year-old female patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose at arm in Aug2019 for immunisation, given at the Physician office.  Medical and family medical history was none. There were no concomitant medications. No history of all previous immunization with Prevenar 13. No prior vaccinations within 4 weeks prior to the first administration date of Prevenar 13. The patient was concomitantly also given another vaccine at that same time, but reporter was unable to provide the name, NDC, Lot, or expiry.  In Aug2019 the patient had the usual pain at the site, achiness, fever, and headache, but her extreme effects were the tingling skin. The reporter thought she had a bad sunburn and couldn't put on her shirt; it hurt to put on her shirt. She ended up with cellulitis at the injection site and was put on antibiotics. She improved after being on the antibiotics 5 days or a week. The event cellulitis at the injection site was considered serious IME, all the other events non serious. No event required a visit to Emergency Room, but all required visit to Physician office. No relevant tests performed. The outcome of bad sunburn and couldn't put on her shirt; it hurt to put on her shirt  was unknown and of all other events was recovering. The patient was coming up for the booster dose. The reporter wanted to know if the side effects were severe enough and if she should get the booster or if it's okay to get it. Caller was unable to provide the NDC, Lot, or expiry for the meningococcal group b rlp2086 since it was given in the doctor's office.  She just knows it was another follow up booster that may have started with "MM".   Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Cellulitis at the injection site; Pain at the site; Achiness; Fever; Headache; Extreme effects were the tingling skin; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; This is a spontaneous report from a contactable consumer (mother) from a Pfizer sponsored program.   A 16-year-old female patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose at arm in Aug2019 for immunisation, given at the Physician office.  Medical and family medical history was none. There were no concomitant medications. No history of all previous immunization with Prevenar 13. No prior vaccinations within 4 weeks prior to the first administration date of Prevenar 13. The patient was concomitantly also given another vaccine at that same time, but reporter was unable to provide the name, NDC, Lot, or expiry.  In Aug2019 the patient had the usual pain at the site, achiness, fever, and headache, but her extreme effects were the tingling skin. The reporter thought she had a bad sunburn and couldn't put on her shirt; it hurt to put on her shirt. She ended up with cellulitis at the injection site and was put on antibiotics. She improved after being on the antibiotics 5 days or a week. The event cellulitis at the injection site was considered serious IME, all the other events non serious. No event required a visit to Emergency Room, but all required visit to Physician office. No relevant tests performed. The outcome of bad sunburn and couldn't put on her shirt; it hurt to put on her shirt  was unknown and of all other events was recovering. The patient was coming up for the booster dose. The reporter wanted to know if the side effects were severe enough and if she should get the booster or if it's okay to get it. Caller was unable to provide the NDC, Lot, or expiry for the meningococcal group b rlp2086 since it was given in the doctor's office.  She just knows it was another follow up booster that may have started with "MM".   Information on the batch number has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is in office now and may receive 2nd dose ofHPV series today after received 1st dose ofGARDASIL 9 on 7/30/2019 as 11-year-old; patient is in office now and may receive 2nd dose ofHPV series today after received 1st dose ofGARDASIL 9 on 7/30/2019 as 11-year-old; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 30-JUL-2019, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis; as an 11-year-old patient.  On 29-JAN-2020, the patient possibly received a second dose (inappropriate schedule of product administration, circumstance or information capable of leading to medication error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles in his left eye; shingles on left side of face; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-JAN-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions by a licensed practical nurse (LPN) as prescribed by a healthcare provider (HCP). The patient suffered the following injuries and was diagnosed on the following dates as result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on left side of face and shingles in his left eye, which were diagnosed on 12-JAN-2018. The outcome of the events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Ophthalmic herpes zoster was considered a medically significant event.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient experienced no symptoms; A patient was administered a dose of PNEUMOVAX 23 after having been administered a dose of PREVENAR 13 on an unspecified date in July 2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.      On 15-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular for prophylaxis (lot number S013489 had been verified to be a valid number; expiration date was reported as 14-SEP-2020 and upon internal validation established as 06-MAR-2021), after the patient had been administered a dose of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) in July 2019 (duplicate therapy error). The patient experienced no symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Oct 18 AE: Hives, rash, itching, swelling  upper arm to elbow.  Oct 18  Treatment: dexamethasone and dyphenhydramine ,   Oct 18  new hives and itching stopped overnight; hives, rash and swelling cleared up in approx. 4 days
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Injection site reaction, Swelling
Clinical narrative: brilliant scarlet chevron 1 inch in size under injection site; evolved to 5cm x 12cm pink lesion.  patient also developed anxiety and foggy feeling.  pateint did seek medical attention.  patient was prescribed hydroxyzine 10mg tablet for swelling and anxiety.  md said not to get next dose
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Localized reaction
Age: 1.08
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infant was administered Kinrix for DTap and IPV immunizations. Infant is 1 yr 1 mo old. Kinrix is licensed for 4 - 6 yrs .
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Erythema, Malaise, Pain in extremity
Clinical narrative: Patient's aunt reported she has had arm soreness, tender, redness that has spread as well as "not feeling well", dizziness, and loss of appetite.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient's aunt reported she has had arm soreness, tender, redness that has spread as well as "not feeling well", dizziness, and loss of appetite.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Urticaria
Clinical narrative: 2. Event Description: Facts; what, where, how it happened and what was going on:  Patient was ordered the Shingrix-Zoster vaccine by PA-C on 29Jan2020 while being seen during a routine visit. HS2 took the Zoster immunization order, provided Patient the zoster recombinant VIS and had him complete the immunization screening form. HS2 then reviewed the immunization screening form, confirmed this was going to be the patient?s first dose and asked the patient if he had any allergies and he stated he did not. The patient agreed to proceed with the immunization, HS2 then prepared the Zoster vaccine and administrered the Zoster vaccine IM into the patient?s Left deltoid. Afterwards, HS2 instructed the patient to wait a minimum of 15-20 mins. in the waiting room to ensure an adverse reaction does not occur. Patient contacted the duty HS, HS3 on 31Jan2020 regarding symptoms he believed were from the Zoster vaccine he received. The patient described how he developed 10/10 arm pain upon arriving home the day he was vaccinated. On 30Jan2020 he also, experienced arm pain and body aches that became present but then reduced. On 31Jan2020 the patient contacted HS3 stating he had hives all over his body. The patient was recommended to go to Urgent Care or ER by the duty HS, HS3 per PA instruction but the patient declined. The patient was then advised to go if symptom(s) worsened and to contact the duty HS again. The patient was instructed to take Benadryl.The patient was contacted on 2-1-2020 and all symptoms had resolved.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient states that he had swelling in his arm (larger area than the administration area) that lasted for approx. 8 days
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Dizziness, Malaise
Clinical narrative: At 6am today (2/7/20) patient complained of not feeling well, was dizzy all night and his temp at that time was 101 F. He stayed home from school all day and his Mother checked his temp at 2.15 pm it was 99.7 F He did take Tylenol during the day. I advised Mom to monitor patient and if he did not recover or if synptoms got worse to go to ER or call PCP
Age: 54.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Condition aggravated, Headache, Hypertension, Injection site swelling, Myalgia
Clinical narrative: fever 101.9, tachycardia, uncontrolled hypertension, myalgia, headache moderate localized swelling to right upper arm at Tdap site
Age: 54.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia, Tachycardia
Clinical narrative: fever 101.9, tachycardia, uncontrolled hypertension, myalgia, headache moderate localized swelling to right upper arm at Tdap site
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Hyperhidrosis
Clinical narrative: Pt reported he did not have any trouble with the 1st vaccine.  He states he had the 2nd Shingrix yesterday and the next day at work he felt lightheaded then broke out in a sweat for about a half hour.  He stated that he kept feeling like he was going to pass out.  He went home and laid down, he did start to fell better, just felt weak.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash, Rash pruritic
Clinical narrative: Patient had flu-like symptoms begin the day after vaccination (1-13-20).  On 1-14-2020, the patient woke up with a widespread itchy rash over most of her body.  Patient started taking Benadryl and topical hydrocortisone for 10 days.  The rash persisted and patient went to her prescriber on 1-29-20 and started oral prednisone and topical triamcinolone, and cetirizine.  The rash is still present every morning when the medications have worn off.  Her provider is recommending allergy testing at this point since she did not have a response to the first vaccination.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash, Swelling
Clinical narrative: Pt received vaccines on the morning of 2/6/2020. Mom notified the office on 2/7/2020 at approx. 1300 stating that patient had developed a generalized rash. She has a reddened raised area to the right thigh (site of Hep A injection) approx. 2 inches in diameter on assessment. Mom stated she also had reddened raised patches on her abdomen, torso, and around her mouth / face. She had given Benadryl and noted this improved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient complained of soreness and a big area of rash on the lower left arm 2 days after getting the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Pyrexia, Tremor
Clinical narrative: Patient experienced chills, fever and shaking.  He also stated that he had trouble breathing.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known symptoms at this time
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Ataxia, Hyporeflexia, Laboratory test normal, Muscular weakness, Pyrexia
Clinical narrative: pt c fevers on 2/3-2/5, presented on 2/6 with ataxia, resolving slowly, some left leg weakness and decreased patellar reflex
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: The pain of the flu shot never went away. kept getting worse and worse. got really bad in december.  right after christmas she had to change her plans for holidays.  she contacted her doctor about the pain.  trouble sleeping at night.  cant lay on the left shoulder. cant do her hair. cant tuck in her shirt. painful doing so.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: muscle pain fever headache fatigue chills nausea all very bad, except for the nausea and headache
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle pain fever headache fatigue chills nausea all very bad, except for the nausea and headache
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Lip blister, Malaise, Pruritus
Clinical narrative: Patient reported feeling tired or general ill-feeling for about 2 days after receiving the vaccination. About 3 to 4 days after vaccination, patient reported a blister on the inside of her bottom lip, and resolved after about 6 days. She also reported a thumb-sized itchy red spot on her right hip, that also occurred about 3 to 4 days after vaccination, and it resolved after about 6 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Developed swelling, redness and warth of the arm and and face. No difficulty breathing, no swelling of the eyes, lips or tongue.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Immediate post-injection reaction, Incorrect route of product administration, Injection site pain, Rotator cuff syndrome
Clinical narrative: Patient complains of approximately one month history of pain in her non-dominant left shoulder. She states her pain began immediately after receiving an influenza vaccine in her left shoulder. She states that vaccine was given subcutaneously instead of intramuscular and she noticed pain starting in her deltoid and radiating up to the posterior aspect of her shoulder, AC joint, subacromial space. She has tried treating her shoulder conservatively with rest and NSAIDs, but reports minimal improvement. She reports occasional popping in her shoulder as well. Her pain is worse with reaching, pushing, pulling, ADLs, getting dressed, above shoulder work, and laying on her left side. Her pain is better with rest and NSAIDs.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt has red area around, painful and hot.  Redness is about size of sticky note.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMRV was given instead of MMR. As well as the Varicalla was given.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Altered state of consciousness, Balance disorder, Dysarthria, Gait disturbance, Imaging procedure
Clinical narrative: Patient states that her left arm became very sore the evening of the shot and she did not feel well as the hours went by. She slept the night and in the morning woke up and had a difficult time walking due to what sounded to me like orthostatic hypotension. She had to sit down due to feeling so unsteady and she described darkness closing in and going away from her like in a tunnel.  She was able to make it back to bed where she attempted to call her daughter but it took several attempts as she described extreme difficulty punching in her daughters phone number. Her daughter stated that when she received the call her mother was slurring her speech. The patient was taken to the hospital and admitted for overnight. Imaging studies were ordered and MRI of the brain showed a small white speck on the brain that night, the speck was not visible on follow up MRI the following day. All other studies were negative. She states that her sister had the same reaction after her pneumonia vaccine but her sister actually lost consciousness and fell in the bathroom, patient did not lose consciousness as far as she knows and she did not fall
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Magnetic resonance imaging brain abnormal, Malaise, Orthostatic hypotension, Pain in extremity
Clinical narrative: Patient states that her left arm became very sore the evening of the shot and she did not feel well as the hours went by. She slept the night and in the morning woke up and had a difficult time walking due to what sounded to me like orthostatic hypotension. She had to sit down due to feeling so unsteady and she described darkness closing in and going away from her like in a tunnel.  She was able to make it back to bed where she attempted to call her daughter but it took several attempts as she described extreme difficulty punching in her daughters phone number. Her daughter stated that when she received the call her mother was slurring her speech. The patient was taken to the hospital and admitted for overnight. Imaging studies were ordered and MRI of the brain showed a small white speck on the brain that night, the speck was not visible on follow up MRI the following day. All other studies were negative. She states that her sister had the same reaction after her pneumonia vaccine but her sister actually lost consciousness and fell in the bathroom, patient did not lose consciousness as far as she knows and she did not fall
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWOLLENNES AND REDNESS OF INJECTION SITE
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Feeding disorder, Paraesthesia
Clinical narrative: PATIENT REPORTED "PINS AND NEEDLES FEELING THROUGHOUT ARMS AND LEGS FOLLOWED BY ICE COLD FEELING FLOWING THROUGH HER VEINS" ABOUT 15 TO 30 MINUTES AFTER SHE RECEIVED THE VACCINE
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Acoustic stimulation tests normal, Blood glucose normal, Computerised tomogram head abnormal, Ophthalmological examination normal, Product administered to patient of inappropriate age
Clinical narrative: The patient is a 17 year, 6 month old male who is here for a well exam. Here with mother. Child eats 3 meals plus snacks and picky eater. Child drinks whole milk. Child drinks 16-24 oz milk per day. Child received OTC multivitamin (occationally). Hearing screening: no concerns with hearing. Vision screening: had vision screening in the past 12 months. Child had no reaction to previous immunization. Discussed safety issues appropriated to age and made recommendations. Confirmed smoke detector in home, wears seat belt, visits dentist regularly and knows how to swim; and no wears helmet when riding bike. Child is enrolled in eleventh grade (junior). Guardian reports no problems at school. Family denies information on community resources at this time. Additional reasons for visit: Teen Risk Assessment is described as the following: In the past 12 months patient has vaped or juuled (quit one month ago) and had anxiety or worries that interfere with sleep or other activities, but not smoked cigarettes, chewed tobacco, drank any beer or wine or other alcohol, smoked marijuana, vaped or waxed marijuana or THC oil, eaten edible candy or brownies with marijuana or THC oil, use other street drugs, had problems with anger control or intentionally harmed self. In the past 2 weeks patient has not had problems with feeling down or depressed or hopeless or little interest or pleasure in doing things. Patient denies having sexual intercourse or oral sex.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Gaze palsy, Posture abnormal
Clinical narrative: Neck tilt Downward eye gaze
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site pain, Lymph node pain
Clinical narrative: * Pain at injection site                              *SX persisted for 2-3 days * Flu-like sx: low grade fever fatigue *tenderness/redness around lymph node at collar bone
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: * Pain at injection site                              *SX persisted for 2-3 days * Flu-like sx: low grade fever fatigue *tenderness/redness around lymph node at collar bone
Age: 74.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Chills, Decreased appetite, Eye irritation, Inflammation, Musculoskeletal pain
Clinical narrative: fever, shiver, pain all over my body special on my neck - shoulder pain - eyes burning- no appetite - my left arm with so much rash red and black color-inflammation and lots of pain! Sick in bed from Dec 1 to Dec 5/2018.
Age: 74.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Neck pain, Pain, Pyrexia, Rash erythematous, Skin discolouration
Clinical narrative: fever, shiver, pain all over my body special on my neck - shoulder pain - eyes burning- no appetite - my left arm with so much rash red and black color-inflammation and lots of pain! Sick in bed from Dec 1 to Dec 5/2018.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Migraine, Rhinorrhoea, Sinus disorder
Clinical narrative: Constant headache since 1/17. Intensity comes and goes. It sometimes feels like a migraine and sometime feels dull. She had tried caffeine, motrin, alka seltzer, vics with no relief. She says it sometimes feels like her sinuses. She had a runny nose. No sore throat. Imitrex rx'd. Followed by allergist. Toradol 60mgxl. Follow up with PCP on 02/20/20.
Age: 26.0
Sex: F
Vaccine: HEPAB, HPV9
Symptoms: Tinnitus
Clinical narrative: Pt noticed ringing in her left ear, kind of like the sound that fluorescent lights make, only louder. It is drown out by white noise, but it is always there if she pays attention, it's quiet or she blocks her other ear. No ear pain, headache, URI symptoms, CP, SOB, nausea diarrhea or dizziness. Has chronic allergies. Followed by allergist. MRI brain to be arranged.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: fever/chills started 8am on 2/5 lasted all day Pt. took 1 Tylenol 650mg. On 2/6 red bump slightly raised size of quarter appeared upon waking located 5 in below injection. Only hurts on touch but radiates heat Today (2/7) spot is pinkish color about same size but a little spread out.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever/chills started 8am on 2/5 lasted all day Pt. took 1 Tylenol 650mg. On 2/6 red bump slightly raised size of quarter appeared upon waking located 5 in below injection. Only hurts on touch but radiates heat Today (2/7) spot is pinkish color about same size but a little spread out.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Hallucination, Moaning, Pyrexia, Tremor, Vertigo
Clinical narrative: Mother reported patient had fever (unsure how high, no working Thermometer) with hallucinations (everything in room spinning, moving fast, flashing, hands shaking, moaning in sleep. The night following vaccinations
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Area of cellulitis at inj site. Started approximately 24h after vaccine. Area 3x4cm. Started on Bactrim DS 1 po q 12 hours for 10 days.
Age: 90.0
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Dry throat, Nervousness, Pharyngeal swelling
Clinical narrative: Pt. said she felt anxious & nervous said throat felt dry. Later stated throat might of felt a little swollen. (Pt. previous had anaphalatic reaction to pcn & is very anxious about getting shots.) Sat in Pharmacy for about 15 min. I called her MD & they suggested the ER. Informed pt. said she was feeling better and was going to go home & relax. Husband was with her and also stated that she gets herself worked up about shots.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Mass
Clinical narrative: 3 days after admin of vaccine mom stated she sees a red spot. 3 days after that it was a bigger red spot and has lumps under skin. Does not seem to bother Pt
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported shoulder pain
Age: 78.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Patient has described that he is experiencing some discomfort on left side following his flu vaccination
Age: 78.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Discomfort
Clinical narrative: Patient has described that he is experiencing some discomfort on left side following his flu vaccination
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rotator cuff syndrome, X-ray
Clinical narrative: Shoulder Impingment. Physical Therapy after Dr Vs
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches, low grade fever, shaking chills, sore arm.   Had to leave work. Lasted about 16 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Body aches, low grade fever, shaking chills, sore arm.   Had to leave work. Lasted about 16 hours.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Lymphadenopathy, Neck pain
Clinical narrative: Pt appears to have received the IM injection near the shoulder joint capsule.  Noted redness to area, pt reports extreme pain to left shoulder and that she is unable to move her arm,  also left neck pain.  Provider noted left lymph node enlargement on clavicle and left neck junction, pt reported pain on palpation.  Severe limitation of motion to left arm with flexion and rotation
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site, Tenderness
Clinical narrative: Pt appears to have received the IM injection near the shoulder joint capsule.  Noted redness to area, pt reports extreme pain to left shoulder and that she is unable to move her arm,  also left neck pain.  Provider noted left lymph node enlargement on clavicle and left neck junction, pt reported pain on palpation.  Severe limitation of motion to left arm with flexion and rotation
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Erythema  and pruritis to upper arm began about 10:30 PM 2/5/2020, peaked about 7:30 AM 2/6/2020, with area of erythema decreasing in size over the course of the day 2/6/2020 and 2/7/2020.  On 2/7/20 at 1:15 PM, area of erythema was 10 X 17 cm and pruritis had resolved. No shortness of breath, wheezing, chest tightness, facial or lip swelling was ever noted.
Age: 19.0
Sex: F
Vaccine: FLUA3, HPV9
Symptoms: Amenorrhoea
Clinical narrative: I missed my period for nearly 2 months after getting vaccination on Dec 18, 2019, including Dec 2019 and Jan 2020 and continues now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Pain, Pain in extremity
Clinical narrative: Sore arm and rash at injection site.  Fatigue, aches.  Persisted for 2 days.  Improved after that.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: My arm became sore at the site of injection. Rather than going away in a day or two, my arm remained sore. It hurt to the point that I couldn't pull a sweater off over my head or reach behind my back with my left arm.The pain has gradually become less, but on the date I submit this report (February 8), almost 4 months later, it still hurts. I have been treating it with physical therapy, exercises, and small doses of ibuprofen. I did see my doctor in November. He thought it was not worth reporting. I have decided to report it since the problem has persisted for so long.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle Pain, Fatigue, Headache, Chills. This is my second dose . Had similar reaction for two days last time.
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Cardiogenic shock, Cerebrovascular accident, Intraventricular haemorrhage, Malaise, Pulseless electrical activity
Clinical narrative: Patient got flu vaccine, started to feel ill within a week where she never felt better. She went into PEA arrest on January 23. She was revived by a family member & admitted to hospital where she was found to have had a stroke from a bleed in her ventricle. She was admitted in cardiogenic shock.
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Resuscitation
Clinical narrative: Patient got flu vaccine, started to feel ill within a week where she never felt better. She went into PEA arrest on January 23. She was revived by a family member & admitted to hospital where she was found to have had a stroke from a bleed in her ventricle. She was admitted in cardiogenic shock.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatitis contact, Erythema, Pruritus, Rash, Swelling face
Clinical narrative: I woke up on Friday, February 7th feeling good. At around noon i shoveled the snow off my neighbors driveway and it was a little while after i got done and went inside that I felt an itch on my back and on my forehead. I thought they were just pimples at first, but then my face slowly felt more tight/swollen. I looked in the mirror and there were a few dime-sized welts on my forehead and cheeks. They werent very itchy at all, Over the next few hours a few more pimple like bumps appeared on my face. Most of my face was red, like hives or poison ivy. Since i felt ok in the head, i didnt go to urgent care or the E.R. I decided to take benadryl and see if it helps. The bumps stayed on my face all night until i went to sleep. I woke up the next day and they are almost fully gone. I still feel good. And that is the point im at while writing this report. A few more notes. My sister has a 1 year old i spend time around and got scratched by him the day before the rash. And also my sister gave birth on February 3rd. Their baby was premature so has been in the hospital for a week. So my sister, brother-in-law, and parents have been switching off going to the hospital every day to be with the baby. I live with my parents. And also i live with a cat (the cat goes outside) and a dog.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: I woke up on Friday, February 7th feeling good. At around noon i shoveled the snow off my neighbors driveway and it was a little while after i got done and went inside that I felt an itch on my back and on my forehead. I thought they were just pimples at first, but then my face slowly felt more tight/swollen. I looked in the mirror and there were a few dime-sized welts on my forehead and cheeks. They werent very itchy at all, Over the next few hours a few more pimple like bumps appeared on my face. Most of my face was red, like hives or poison ivy. Since i felt ok in the head, i didnt go to urgent care or the E.R. I decided to take benadryl and see if it helps. The bumps stayed on my face all night until i went to sleep. I woke up the next day and they are almost fully gone. I still feel good. And that is the point im at while writing this report. A few more notes. My sister has a 1 year old i spend time around and got scratched by him the day before the rash. And also my sister gave birth on February 3rd. Their baby was premature so has been in the hospital for a week. So my sister, brother-in-law, and parents have been switching off going to the hospital every day to be with the baby. I live with my parents. And also i live with a cat (the cat goes outside) and a dog.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever and erythema, warmth, pain, tenderness at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Stiff neck, injection arm pain/redness, headaches, dizziness, weakness, severe fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff neck, injection arm pain/redness, headaches, dizziness, weakness, severe fatigue
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: I administered an expired vaccine.  The expiration date was 1/2020 and the date of administration was 2/5/2020.  I let the patient know by phone call and advised him to report any adverse events to either us or the VAERS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Insomnia, Paraesthesia
Clinical narrative: pt stated feeling anxious with paresthesia and was unable to sleep night of vaccine due to symptoms. pt feels it will go away in a day or so on its own.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Induration, Swelling
Clinical narrative: localized swelling  and induration up to 6cm
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Not many side effects the day after, but had a large 5 inch by 5 inch red inflamed area near the site of injection. It was warm to the touch and has still been there since the date of injection
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient reported flu like symptoms, body aches, and a fever of 101 degrees F starting the day after the injection and lasting for a few days and numbness in her feet and legs starting 5 days after the injection and also lasting for a few days
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus
Clinical narrative: the morning after the shot I experienced itching of the face and neck which has continued to this date. I am also experiencing diarrhea.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: the morning after the shot I experienced itching of the face and neck which has continued to this date. I am also experiencing diarrhea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache- 1 day shivering, body aches, fatigue - 3 days