chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: No additional adverse event reported; Proquad administered to an adult patient; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse, referring to a female adult patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 08-OCT-2020, the patient was vaccinated Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) 0.5 milliliter once, lot # S038146, expiration date reported as 25-MAY-2021 , for prophylaxis (strength and route were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter once, lot# S019463, expiration date reported as 24-JUN-2021, for prophylaxis (strength and route were not reported) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-MR II) prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX).
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: vaccine leaking out during an injection and syringe has been disposed of at the time of this report, no AE; spraying into a consumer's left eye due to the vaccine leaking out during an injection and the vaccine spilled on the left eye, no AE; the vaccine spilled on the arm and clothing, no AE; consumer did not receive a full dose, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographic) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] During administration time the vaccine leaking out during an injection and syringe has been disposed of at the time of this report (syringe issue), spraying into a patient left eye and the vaccine spilled on the left eye (exposure via eye contact), the vaccine spilled on the arm and clothing (exposure via skin contact) and did not receive a full dose (underdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiry date: 30-Jun-2021) via an unknown route in the arm for prophylactic vaccination.  It was actual medication error case due to underdose and exposure via eye contact and exposure via skin contact (latency on same day). It was reported that Fluzone Quadrivalent spraying into a patient left eye due to the vaccine leaking out during an injection. The Pharmacist reported that the needle was on tight; that after the event the needle was checked and was tight; that there was no damage noted to the syringe on inspection after the event; that the syringe has been disposed of at the time of this report; that she knows the needle was injected into the arm and the vaccine was being administered; that the consumer did not receive a full dose; that the consumer reports the needle never penetrated his arm or that the injection was not in all the way; that the consumer is a physician; that the vaccine spilled on the arm, clothing, and the left eye.  It was also the case of Syringe issue.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Fever,chills, headache, cough, aches
Age: 23.0
Sex: F
Vaccine: UNK, FLUC4
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: I got a shot for the Flu on 9/18/2020 and the next day experienced lack of mobility and extreme pain in shoulder. The extreme lack of mobility lasted about four days. Currently, 10/13/2020, I am still experiencing extreme pain when shoulder is moved, and somewhat lack of mobility due to pain. I have been in contact with my Primary Care Doctor, who tried steroids, which did not help, so I got an MRI and awaiting results.
Age: 23.0
Sex: F
Vaccine: UNK, FLUC4
Symptoms: Pain in extremity
Clinical narrative: I got a shot for the Flu on 9/18/2020 and the next day experienced lack of mobility and extreme pain in shoulder. The extreme lack of mobility lasted about four days. Currently, 10/13/2020, I am still experiencing extreme pain when shoulder is moved, and somewhat lack of mobility due to pain. I have been in contact with my Primary Care Doctor, who tried steroids, which did not help, so I got an MRI and awaiting results.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Hard lump and swelling and redness at injection site lasting for longer than 2 days. Seen by doctor and advised to take otc allergy medicine
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Patient experienced 100 degree fever, chills, shaking for 24 hours. Sore arm for 3 days
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Very sore arm, stiff neck and headache, body aches, fever, trembling, shivering, hand shaking.  I took 600 mg of ibuprofen 4 hours after the onset of symptoms on the day of vaccination.  Side effects continued the next day and I took 400 mg of ibuprofen every 4 hours.  The ibuprofen controlled the fever and all symptoms with the exception of the stiff neck.  Side effects continued into the 3rd day morning, but subsided by mid day.  I was vaccinated on a Saturday morning at 11 a.m. and side effects started with a sore arm immediately, and the rest of the side effects started at approx. 5 p.m. that afternoon.  They lasted until about 2 p.m. on Monday.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Very sore arm, stiff neck and headache, body aches, fever, trembling, shivering, hand shaking.  I took 600 mg of ibuprofen 4 hours after the onset of symptoms on the day of vaccination.  Side effects continued the next day and I took 400 mg of ibuprofen every 4 hours.  The ibuprofen controlled the fever and all symptoms with the exception of the stiff neck.  Side effects continued into the 3rd day morning, but subsided by mid day.  I was vaccinated on a Saturday morning at 11 a.m. and side effects started with a sore arm immediately, and the rest of the side effects started at approx. 5 p.m. that afternoon.  They lasted until about 2 p.m. on Monday.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Vomiting
Clinical narrative: Severe chills and vomiting
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness, Eye movement disorder, Moaning, Syncope, Tremor
Clinical narrative: 10 min after the shot was given he lost vision, fainted, eyes rolled back, moaning , and started to shake
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash, Rash pruritic, Sensation of foreign body, Urticaria
Clinical narrative: Pt was in the office given the vaccine at 1103am. Patient then went to work after 10-15 min of observation, with no interaction. Patient then went to the ED at 2209 with notation of Allergic Reaction. She presented to the ED with Hives and Pruritus. Notation from ED says that within 30 minutes patient broke out in a rash on Abdomen & Arms that is Pruritic. Denied swelling of lips and tongues, but felt as if something was stuck in her throat. NO wheezing, stridor, shortness of breath, nausea or vomitting. Patient is allergic to Carbofed DM which contains benadryl. However patient takes Claritin and Zyrtec PRN with no issues.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Joint swelling
Clinical narrative: Nausea, 2 pm, continue thru evening   Diarrhea onset 3:30 pm, off and on thru 8 am at report time  Severe shoulder soreness, joint noticeably  swollen  Severe headache, onset around 4 pm day of vaccine  no relief from tylenol, headache continue thru to time of reporting   Feeling feverish, although no fever on thermometer  Extreme tiredness
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, 2 pm, continue thru evening   Diarrhea onset 3:30 pm, off and on thru 8 am at report time  Severe shoulder soreness, joint noticeably  swollen  Severe headache, onset around 4 pm day of vaccine  no relief from tylenol, headache continue thru to time of reporting   Feeling feverish, although no fever on thermometer  Extreme tiredness
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Flushing, Hyperhidrosis, Pallor
Clinical narrative: This flu shot was received during an outreach event at a local school district for employees of the school district. Patient  voices prior to vaccination that this flu shot is her 1st flu shot. screening for negative for contraindications. Received flu vaccine.  The  school nurse called. The patient reports eating lunch then started to feel bad around 1pm.  She threw up,  dizzy, pale, sweat, flushed, BP  138/97.  Wearing mask, it made it worse, Temp 98.2.  Was encouraged to lay down for a while,  BP went down slightly to 132/92.  About 1.5 hour later, BP went down more and  felt better to go home.  Patient informed school nurse that she felt dizzy earlier in the week on Monday  while traveling on a windy road to and from a volleyball game. Patient was encouraged by school nurse to get a pregnancy test but patient denies possibility due to oral contraceptive use.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This flu shot was received during an outreach event at a local school district for employees of the school district. Patient  voices prior to vaccination that this flu shot is her 1st flu shot. screening for negative for contraindications. Received flu vaccine.  The  school nurse called. The patient reports eating lunch then started to feel bad around 1pm.  She threw up,  dizzy, pale, sweat, flushed, BP  138/97.  Wearing mask, it made it worse, Temp 98.2.  Was encouraged to lay down for a while,  BP went down slightly to 132/92.  About 1.5 hour later, BP went down more and  felt better to go home.  Patient informed school nurse that she felt dizzy earlier in the week on Monday  while traveling on a windy road to and from a volleyball game. Patient was encouraged by school nurse to get a pregnancy test but patient denies possibility due to oral contraceptive use.
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: Hives all over body
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Night sweats, Rash
Clinical narrative: Night sweats and joint pain. Rash on both arms.   Tx with over the counter ibuprofen and antihistamine.   Sx lessening as of 0647 hours.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Impaired work ability, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Anticipated/expected Muscle soreness for two days after injection. One week after injection I started to experience intermittent Nerve pain, weakness, numbness in the shoulder joint. I kept thinking it would improve, it has not. The pain has increased over the past two weeks and is now limiting ADL and job performance because of restricted movements and strength in left arm.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Neuralgia, Pain
Clinical narrative: Anticipated/expected Muscle soreness for two days after injection. One week after injection I started to experience intermittent Nerve pain, weakness, numbness in the shoulder joint. I kept thinking it would improve, it has not. The pain has increased over the past two weeks and is now limiting ADL and job performance because of restricted movements and strength in left arm.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event was experienced however wrong vaccine was administered. Patient was supposed to receive Prevnar 13 and received Fluad 65+ instead. Experienced no symptoms.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pallor, Pruritus, Skin warm, Yellow skin
Clinical narrative: Patient woke up the next morning to have her assisted living staff take her blood pressure and noticed her arm was extremely red. Eventually moved all the way down her arm to almost her elbow. Area was very hot and itchy. After a day or so, area turned a pale yellow.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 99.2 as of 10:30 a.m. on 10/13/2020.
Age: 41.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Skin warm, Swelling
Clinical narrative: tingling, numbness, warm, swollen, redness on left arm and hand
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site warmth, Pain, Pyrexia
Clinical narrative: FEVER, PAIN, REDNESS, SWELLING,  BODY ACHES, HEADACHE, WARMTH AT SITE
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: FEVER, PAIN, REDNESS, SWELLING,  BODY ACHES, HEADACHE, WARMTH AT SITE
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Erythema, Headache, Pain, Pyrexia
Clinical narrative: Local swelling, redness, pain. Fever, chills, headache within 6-8 hrs of injection
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Swelling
Clinical narrative: Local swelling, redness, pain. Fever, chills, headache within 6-8 hrs of injection
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Peripheral swelling, Pruritus, Rash
Clinical narrative: 2 hours following injection patient started to feel itching and discomfort at waist line, he did not see anything then, but later that evening he developed a rash to his trunk and sides and swelling of the right arm, patient is a physician so he took prednisone, woke the next more with rash still present on trunk and now also on his face, he called an infection disease provider that he knows personally and discussed his symptoms to which he was instructed to take another dose of prednisone and that this reaction is not uncommon as of 10/13/2020 all symptoms have resolved and patient is feeling well.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Headache, Influenza like illness, Lethargy, Pain
Clinical narrative: Panful arm for 1 day but starting 24 hours after vaccine I have had flu like symptoms- lethargy, body aches, headache, plugged ears
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Panful arm for 1 day but starting 24 hours after vaccine I have had flu like symptoms- lethargy, body aches, headache, plugged ears
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction
Clinical narrative: State anaphylaxis per staff from family provider
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site mass
Clinical narrative: Lump under injection site
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: About 1/2 hour after vaccine administration, my left deltoid swelled (mildly), and my left hand, arm, and shoulder started tingling.  I never lost feeling completely, but it took about 2 days total for the tingling to completely go away.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza like illness, Injection site mass
Clinical narrative: Lump under injection site and flu like symptoms
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Immobile, Sensory loss
Clinical narrative: Patient reports loss of sensation in arm and immobility.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Mass
Clinical narrative: soft ball size lump
Age: 62.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Temp to 100.1, headache, nausea, fatigue, myalgia
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site mass
Clinical narrative: Lump under injection site
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood glucose normal, Feeling abnormal, Pallor, Peripheral coldness
Clinical narrative: After baby was given her shots, the nurses noted her to be a bit pale. We checked her, and she initially was pale, and seemed dazed/glazed, though she  was awake, pupils were equal and reactive to light, her hands and feet were cold. We could not get a pulse ox reading, then after rubbing her, and stimulating her, she cried louder, and color seemed to return, and when oxygen was placed over her face, her face color improved, more pink, and on rubbing her feet to warm them up, they turned pink as well. Rechecked her pupils, equal and reactive, her fingerstick BG was 86 mg/dl, and was normal. Temperature was 98.6 F, tympanic.  She seemed tired, but dad said she seems back to normal as her color was now her regular pink self.  Doctor decided it would be best to have baby checked out at the ER. Dad agreed, and the Doctor called the ER and spoke with Doctor on duty, and discussed the case. He will check the baby.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immobile, Mobility decreased, Musculoskeletal disorder, Pyrexia
Clinical narrative: Patient developed fever on 09/26, tested for COVID on 09/28 and received a positive COVID result on 09/30. On 10/01, he first began having mobility issues described as trouble getting in and out of bed. On 10/02, his legs collapsed and was completely immobile and emergency services was called. Patient was diagnosed in the hospital  with Guillain-Barre syndrome.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient developed fever on 09/26, tested for COVID on 09/28 and received a positive COVID result on 09/30. On 10/01, he first began having mobility issues described as trouble getting in and out of bed. On 10/02, his legs collapsed and was completely immobile and emergency services was called. Patient was diagnosed in the hospital  with Guillain-Barre syndrome.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: achy, headache, fatigue for 48 hrs after injection, then mid fatigue and on /off headache; day 6 after injection developed total body rash (hives, large red patches, burning sensation, paresthesia (felt line pins and needles under skin); took benadry 50mgs x2 with good response; next day same rash, but worse then previous day; took same amount of Benadryl and added Zantac x2; currently continue to have the burning sensation all over body but no visible rash
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: achy, headache, fatigue for 48 hrs after injection, then mid fatigue and on /off headache; day 6 after injection developed total body rash (hives, large red patches, burning sensation, paresthesia (felt line pins and needles under skin); took benadry 50mgs x2 with good response; next day same rash, but worse then previous day; took same amount of Benadryl and added Zantac x2; currently continue to have the burning sensation all over body but no visible rash
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old female was administered Dtap vaccine.  No adverse events or outcomes noted.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache, chills, fever, arm soreness
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Rash
Clinical narrative: pt stated that she experienced heart raising and rash and last from 10/07 to 10/08.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Blood test normal, Chest pain, Computerised tomogram normal, Culture urine negative, Diarrhoea
Clinical narrative: Severe nausea, moderate vomiting, upper sternum pain, mild diarrhea first 24 hours only.  Nausea and pain continued for duration of week through Friday, August 9, when patient was taken to emergency room due to pain intensity.  Patient unable to hold down solid food for medication during most severe symptoms.    Patient was place in observation status from 1200 PM Friday, 10/9 and then discharged back to hospice care on Monday, 10/12.  Patient is currently still recovering, but pain and nausea have been remediated.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Severe nausea, moderate vomiting, upper sternum pain, mild diarrhea first 24 hours only.  Nausea and pain continued for duration of week through Friday, August 9, when patient was taken to emergency room due to pain intensity.  Patient unable to hold down solid food for medication during most severe symptoms.    Patient was place in observation status from 1200 PM Friday, 10/9 and then discharged back to hospice care on Monday, 10/12.  Patient is currently still recovering, but pain and nausea have been remediated.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on upper torso mostly on right and left arms with severe itching  beginning on Saturday, 2 days after injection and continues to this date of 10.13.2020.  Using topical treatment external Analgesic - Pramoxine HCI 1% and Diphenhydramine HCI 2% as needed.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Syncope
Clinical narrative: The patient received both shots at the same visit in the same arm at approximately 4:30 pm on 10/10/2020. The patient then began to experience soreness and redness in the arm later in the evening. At that time his arm was becoming more sore throughout the evening. The following day  on Sunday  morning 10/11/2020 his arm was red from across his chest to the left elbow. He felt worse and at that time he fainted on a walk in the morning. This resulted in him being admitted to the hospital for 2 days and released in the morning of 10/13/2020.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm
Clinical narrative: majority of upper arm very red and warm.  Patient states she came down with a fever of 103 the following day and was diagnosed with cellulitis at the hospital where she revceived IV antibiotics
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Malaise, Mobility decreased
Clinical narrative: Patient reports sore arm (could not lift arm at all) for 7 days. Patient lost appetite and could not eat, had the chills, headache, and felt very seriously "sick" for at least 5 days after administration.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports sore arm (could not lift arm at all) for 7 days. Patient lost appetite and could not eat, had the chills, headache, and felt very seriously "sick" for at least 5 days after administration.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: localized cellulitis, pain, swelling, redness warmth to arm, vaccine given too low.  Started on doxy to treat cellulitis.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: localized cellulitis, pain, swelling, redness warmth to arm, vaccine given too low.  Started on doxy to treat cellulitis.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PT STATES SHE DEVELOPED A HEAD TO TOE ITCHY, RED RASH 1/2 HOUR AFTER RECEIVING THE FLU VACCINE
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: shoulder was sore couldn't move it asked if muscle or joint and she said she wasnt sure
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: About 4 hours after recieving vaccine in Left arm patient experienced extreme soreness and pain at injection site. He was unable to lift his arm and felt very sore for a full 48 hour period before recovering. He tried taking tylenol/ibuprofen but reported they did not resolve the pain. Also he tried applying aspercreme lidocaine 4% to the site and that provided some relief but it was not until a full 48 hours from the shot that he finally experienced relief from soreness.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Around 4:30 I started to have body aches, nausea, and uncontrollable chills. The chills lasted for about 2 1/2 hours. Today, I have a headache, aching in my legs, and a headache.
Age: 71.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Arthralgia, Injection site swelling, Pain
Clinical narrative: Patient  reported that 3 days following vaccination, his left arm where he received the Fluad vaccine "blew up," spread to his other arm, and then he had pain radiating all the way down to his hip.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Rash on right arm, and trunk. Benadryl, anti-itch oint. Still red today.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Blood test, Chest X-ray, Culture, Pruritus, Pyrexia
Clinical narrative: Rash, fever,  and itchy
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Rash
Clinical narrative: Rash, fever,  and itchy
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site inflammation, Administration site pain, Injection site erythema
Clinical narrative: Redness, inflammation and pain surrounding the site of administration
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Loss of consciousness, Mydriasis, Posture abnormal
Clinical narrative: Patient was given a  flu vaccination intramuscularly.  Approximately 45 seconds after receiving vaccine, patient slumped over in chair and lost consciousness. Her eyes were open but she was completely unaware of surroundings. Her pupils were extremely dilated. Her mother was also present in room, and being shouting her name, tapping and shaking her to try to come out of her state.  Soon, patient had trouble breathing and was not breathing for a few seconds. Patient came to, but then gasping for air, and had a mild seizure . Patient eventually came out of state, drank some orange juice and relaxed for about 10 minutes after episode. Called mom about an hour and a half after vaccine, and mom stated patient had a headache.  Patient has a prior history of anoxic seizures and vasovagal syncope.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory arrest, Seizure
Clinical narrative: Patient was given a  flu vaccination intramuscularly.  Approximately 45 seconds after receiving vaccine, patient slumped over in chair and lost consciousness. Her eyes were open but she was completely unaware of surroundings. Her pupils were extremely dilated. Her mother was also present in room, and being shouting her name, tapping and shaking her to try to come out of her state.  Soon, patient had trouble breathing and was not breathing for a few seconds. Patient came to, but then gasping for air, and had a mild seizure . Patient eventually came out of state, drank some orange juice and relaxed for about 10 minutes after episode. Called mom about an hour and a half after vaccine, and mom stated patient had a headache.  Patient has a prior history of anoxic seizures and vasovagal syncope.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Pyrexia, Tremor, Urticaria
Clinical narrative: 100.9 fever, trembling and shaking, joint pain, tired, couple spots of hives
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Eating disorder, Headache, Injection site pain, Pain
Clinical narrative: Patient had a headache, pains, some issues eating food, and ache at the injection site.  She claimed that it resembled the symptoms that she had when having the shingles 20 years ago.  She is using ice, otc pain med and benadryl to treat the reaction and it seems to be working.   She only needed to call the Pharmacist and the doctors office for guidance, no visit or ER needed.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient experienced shoulder pain for a period of time greater then 5 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Musculoskeletal discomfort
Clinical narrative: Pt described an on and off burning sensation on one side of her back lasting around 1 month, and starting 1 week following vaccination. pt has had 2 active shingles outbreaks in her lifetime and describes this as similar, but without the itching.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling in upper arm, hot to the touch, redness to elbow, headache, body aches.
Age: 67.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient noticed swelling in the right arm 2-3 hours after administration. Patient reports that her entire arm and shoulder were swollen. She reports that she almost went to the emergency room, but ultimately decided not to. Patient has not had any breathing difficulty or swelling in the head or neck.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Nausea, Sleep disorder, Vomiting
Clinical narrative: dizzy, nausea, vomiting passed out for 1-2 minutes,  said he could not sleep well the night he received the vaccine
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Soft tissue swelling
Clinical narrative: PT DEVELOPED SOFT TISSUE SWELLING IN UNDERARMAND NECK AREA.   DENIED PAIN, SWELLING, IRRITATIN OR REDNESS AT INJECTION SITE.  MD RECOMMENDED PT NOT GET FLU VACCINES IN THE FUTURE AND PT IS TAKING IBUPROFEN FOR PAIN ASSOCIATED WITH SWELLING.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: The patient received the vaccine in our counseling room and about 3 minutes after exiting the room the patient had slowly fainted and was caught by his parents prior to hitting the floor. The patient hasn't had this experience with flu shots in previous years, and patient's father has also experienced the same type of reaction after other vaccines. The patient and his parents declined to go seek medical care after leaving the store as patient stated he was feeling better and felt stable standing and walking on his own .
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Upon calling to have patient come in for second dose, patient stated that she developed an orange sized red mark around the injection site that lasted almost 5 weeks and is still slightly visible (as of today 10/13).
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain
Clinical narrative: Pt experienced a very edematous and painful injection site and was unable to lift her arm unless using the other arm to do so.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt received flu vaccine in L arm at 5:55 pm. Pt was Alert and orientated but very nervous prior to vaccine administration.  At 5:58 pt stood up and knees buckled, eyes rolled back and skin was pale. Lowered pt to floor and had regained consciousness in 5-8 seconds. Bp=100/48 P=60 at 6:00 pm, BP=98/50 P=62 at 6:06pm, BP=90/40 P=74 at 6:10pm. A&O x 4. Rescue called to assess and determined to be vasovagal reaction.  Mom refused transport to hospital. Pt went home with mom for followup  with PCP.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient's arm swelled around the site of injection.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Veteran received vaccine, sat in waiting area for 15  minutes. left with wife and then returned about 15 min later. Veteran reported "hives" on his face. Small fine red bumps observed on both cheeks, neck and anterior and posterior trunk. Veteran denied shortness of breath, itching, swelling of tongue and lips. No angioedema observed. Veteran given 50mg PO Benadryl and observed for additional 15 minutes. Veteran escorted to his car, wife present and waiting. Provided information on contacting 911 for any breathing issues/difficulty.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Arm tenderness, Swelling, redness, warm to touch
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: A few hours after getting the vaccine the patients arm felt funny and she noticed swelling and redness from her deltoid to the crease of her elbow. The area was hot to the touch and itchy. She took Benadryl and applied hydrocortisone cream. We looked at the arm today and she said it had not changed much. Encouraged her to continue with Benadryl and to seek medical attention if it did not improve.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Urticaria
Clinical narrative: Pt received flu vaccine at 11am in the L Deltoid at work. Around 4:30pm patient felt left facial numbness and hives and redness on her cheeks. Upon getting home that evening (between 5 and 5:30pm), patient took 1 Benadryl and reaction subsided.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: Mom called and  reported that 17 hours after injection was given patient presented with 102.5F fever the rest of that day along with chills, dizziness, and fatigue. Mom reported the next day patient was back to baseline with no apparent symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Skin exfoliation
Clinical narrative: 48 hrs after injection, from just above right knee to right foot, bright pink manifestation in skin leading to skin peeling within 15 minutes and blistering within 30 minutes; looked like burn.  continuing large up to 3" x 3"  blistering through 48 hours and beyond.  MD described as consistent with chemical or scalding burn both of which are out of the realm of possible causes. No fever, no severe pain. No history of bullous pemphigoid.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient is stating that the injection site from his shingrix shot given on 8/8/20 is still sore and painful on the day he called the pharmacy which is 10/13/20.  The pain has not resolved or lessened since the day of the injection according to the patient.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reported redness and swelling in right bicep after IM deltoid injection. Reports that redness and swelling is beginning to subside as of current date.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Reported on 10/7/2020 with red raised rash and itching on arms abd and groin area with Prednisone 50 mg ordered with resolved issues as of 10/9/2020
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial infection, Biopsy skin, Blister, Peripheral swelling, Rash
Clinical narrative: Patients daughter said 3 days after vaccination patient had swelling and eruptions on his arm that were blistered and oozing. He went to ER and was treated for bacterial infection but it did not work. He had a skin biopsy done and no results back yet . Pharmacist at hospital said for us to report.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin weeping
Clinical narrative: Patients daughter said 3 days after vaccination patient had swelling and eruptions on his arm that were blistered and oozing. He went to ER and was treated for bacterial infection but it did not work. He had a skin biopsy done and no results back yet . Pharmacist at hospital said for us to report.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Patient experiencing stiff arm, only able to lift ~45 degrees
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports having left shoulder/lateral upper arm pain since receiving the vaccine on 9/23/20.  Pain has persisted, ROM slightly limited secondary to pain.  She is going to try alternating warm and cool compresses, over-the-counter naproxen as directed as needed, and physical therapy.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Lethargy
Clinical narrative: Became lethargic within an hour after getting the shot. Became foggy headed and didn't have any energy. Sat in chair  for 3-4 hours after the administrator left.  Went into the bedroom and laid down on the bed, was a little frightened to stand for fear of losing his balance. Got up and went in the kitchen to microwave something and went back to bed. The next morning, felt fine.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Hypoaesthesia, Neck pain, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient states that at approximately 2230 on 10/9/2020 she started to experience numbness and tingling in her hands and feet. Client states that she also experienced a headache and pain on the left side of her neck. Client states that she was concerned that it was Guillen-Barre Syndrome so she went to the emergency department. The ED diagnosed her with peripheral neuropathy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: First dose of vaccine was administered. After administration it was realized that the lyophilized  component was expired.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Rhinalgia
Clinical narrative: nasal swelling/pain
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Client states hours after the second vaccine she had a fever, flu like symptoms, headache which resolved by the following day
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Tingling and numbness in arm. History of cervical and thoracic spine fusion. She was feeling the spasms prior to receiving the flu shot and still feels the same spasms.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: The name of the  flu shot was FLUBLOCK. I don't know if it is Fluad or one of the other types nor who the manufacturer is. I also reported adverse reactions to the pharmacy. Symptoms: soreness at injection site for 4 days (normal for me) plus headache, nausea, sore muscles and fatigue. Symptoms lasted 4 days. Treated on day 3 with one extra strength TYLENOL tablet. NOTE: checked temperature multiple times and all were within normal range.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Patient reported adverse event in person at pharmacy on 10/13/2020. Per pt, patient received flu shot on 10/09/2020 and then starting from the next day, 10/10, she started feeling numbness on one side of her face. Pt denies previous history of reaction to flu vaccines besides minor flu-like symptoms. She opted for watchful waiting until 10/13 when she decided to present to urgent care for further evaluation when numbness had not resolved. Per pt report, urgent care provider diagnosed her with Bell's Palsy and was prescribed a course of prednisone 60mg daily for 7 days.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Fatigue, Fear of falling, Gait disturbance
Clinical narrative: Within 2 hours, the injection site was very sore. The pain was on the upper back on the left side. Then it was in the left shoulder blade. Felt tired, went to bed early and woke up next morning with soreness and limping in the left leg. Had problems walking and afraid of falling because of the pain. Went to urgent care, the doctor looked at it to find the soreness. Continued to be sored. Best way to treat it is to stay off of it and take Naproxen. Took Naproxen. Keep taking it as along as there was soreness. Feeling ok now.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Within 2 hours, the injection site was very sore. The pain was on the upper back on the left side. Then it was in the left shoulder blade. Felt tired, went to bed early and woke up next morning with soreness and limping in the left leg. Had problems walking and afraid of falling because of the pain. Went to urgent care, the doctor looked at it to find the soreness. Continued to be sored. Best way to treat it is to stay off of it and take Naproxen. Took Naproxen. Keep taking it as along as there was soreness. Feeling ok now.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Blood potassium decreased, Computerised tomogram head normal, Feeling hot, Full blood count normal, Metabolic function test
Clinical narrative: Feeling of warmth all over almost immediately following vaccination then 5 minute generalized tonic seizure 3 hours after administration
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Tonic convulsion
Clinical narrative: Feeling of warmth all over almost immediately following vaccination then 5 minute generalized tonic seizure 3 hours after administration
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Decreased appetite, Erythema, Headache, Injection site pain
Clinical narrative: Several hours post vaccine I was feverish, had severe headache and arm began to become red.  I also became nauseous.  The redness on arm continued to become larger, redder and itchy.  The location of this lesion was beneath the injection site (about three inches ) .  The injection site itself was just slightly sore to the touch but the large red, swollen, itchy area continued to enlarge, my headache remained, nausea remained and I have had no appetite.  My temperature was about 100 degrees for days, it was normal last night and today.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Pyrexia, Swelling, Vaccination complication
Clinical narrative: Several hours post vaccine I was feverish, had severe headache and arm began to become red.  I also became nauseous.  The redness on arm continued to become larger, redder and itchy.  The location of this lesion was beneath the injection site (about three inches ) .  The injection site itself was just slightly sore to the touch but the large red, swollen, itchy area continued to enlarge, my headache remained, nausea remained and I have had no appetite.  My temperature was about 100 degrees for days, it was normal last night and today.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: the evening of vaccination, the patient was woken in the night with pain in the left deltoid injection site. the next day the left shoulder and arm was extremely sore. after 2 days the site turned red and hot to touch. the redness and swelling extended down the arm and into the inside bend of elbow.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: R arm under the vaccine area - below on lower arm yesterday redness and itching and swelling started  also flu shot in the other arm which is fine
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling of eyelid
Clinical narrative: Client states that approximately 4 hours after receiving the Flucelvax, her eyelids began to swell.  Especially the left eyelid.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given a high dose flu shot and should have received a regular flu shot as patient is only 64.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram normal, Erythema, Paraesthesia, Pruritus
Clinical narrative: Pt had flu shot at 1023 and then at 1025 she reported to the MA she had "feelings fo tingling, Shortness of Breath, itching and that her back of tongue felt "itch."" No hives noted. She had visible redness to her neck but no swelling and was given two instant icepacks to the back of the neck and to the decolletag. She was immediately rushed to the ER 30 feet away via a wheelchair and placed in Room 18 where she was given the following medications : IM epinephrine X 1 (0.4mg IM 1:1000 injection), Pepcid 20 mg IV push and Benadryl 50 mg IV push and Decadron 10 mg IV push (per ER RN). Patient reported she self medicated later after discharge she self medicated with oral Benadryl with 25mg evening of 10/8/2020, adds for treatment of mild itching she still had. Saturday 10/9/2020 "she felt better and did not need to take additional medications at home." Sunday 10/10/2020 reported no symptoms
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Tongue pruritus
Clinical narrative: Pt had flu shot at 1023 and then at 1025 she reported to the MA she had "feelings fo tingling, Shortness of Breath, itching and that her back of tongue felt "itch."" No hives noted. She had visible redness to her neck but no swelling and was given two instant icepacks to the back of the neck and to the decolletag. She was immediately rushed to the ER 30 feet away via a wheelchair and placed in Room 18 where she was given the following medications : IM epinephrine X 1 (0.4mg IM 1:1000 injection), Pepcid 20 mg IV push and Benadryl 50 mg IV push and Decadron 10 mg IV push (per ER RN). Patient reported she self medicated later after discharge she self medicated with oral Benadryl with 25mg evening of 10/8/2020, adds for treatment of mild itching she still had. Saturday 10/9/2020 "she felt better and did not need to take additional medications at home." Sunday 10/10/2020 reported no symptoms
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Balance disorder, Chills
Clinical narrative: Stomach ache/pain LUQ x 4 hours: no treatment.  resolved on its own Fever and chills between 101.6-102.6 intermittently for 40 hours, treated with q4hours ibuprofen, acetaminophen,plus  increased fluids, sleep, rest, inactivity Light-headed and balance issues with extreme weakness and fatigue: treated with sleep, rest, inactivity Severe aches and pains entire body including all joints: treated as for fever. Especially severe headache with photophobia: treated as above plus wearing sunglasses indoors and closing all drapes, avoiding all light. Most acute symptoms resolved within approximately 40 hours although I continued to have exagerated fatigue, muscle aches and intermittent temperature spikes for the next 08 days beyond initial severe reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Stomach ache/pain LUQ x 4 hours: no treatment.  resolved on its own Fever and chills between 101.6-102.6 intermittently for 40 hours, treated with q4hours ibuprofen, acetaminophen,plus  increased fluids, sleep, rest, inactivity Light-headed and balance issues with extreme weakness and fatigue: treated with sleep, rest, inactivity Severe aches and pains entire body including all joints: treated as for fever. Especially severe headache with photophobia: treated as above plus wearing sunglasses indoors and closing all drapes, avoiding all light. Most acute symptoms resolved within approximately 40 hours although I continued to have exagerated fatigue, muscle aches and intermittent temperature spikes for the next 08 days beyond initial severe reaction.