chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia, Paraplegia
Clinical narrative: Tingling and numbness started at feet and quickly worked it's way up to legs and then lungs/heart/chest, hands, arms, then face. Was hard to breathe, lips turned purple. Severe numbness to legs/feet. Got breathing under control but legs remained numb/tingling. Could hardly walk for 5 days. Brain told legs to walk but legs were only able to do it off of a reflex or muscle memory. At night I would try to go to sleep but body would immediately wake me up gasping for air. After getting proper breathing back I would fall back asleep where I would immediately feel like I stopped breathing again and wake up gasping for air. All night long for 5 nights straight. No fever. Called primary care doctor still hasn't returned my call. I called the pharmacy in which gave me the vaccine day 1 and they told me that they have never heard of a side effect like this with the imovax shot, but to monitor it or go to ER. Then called hospital where lead ER nurse told me to monitor or go to ER. We decided to monitor for financial reasons.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sinus headache
Clinical narrative: Numbness in 2 fingers and slow onset sinus headache
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Face oedema, Hypotension, Loss of consciousness, Throat tightness
Clinical narrative: hypotension. loss of consciousness, difficulty breathing, throat constriction, facial edema
Age: 59.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Employee states that she woke up at 10pm with a swollen lower lip and right eye. She took Allegra and went back to bed. Symptoms resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor, Vision blurred, Vitreous floaters
Clinical narrative: Chills, shaking, blurred vision in the left eye with black floats
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Laboratory test
Clinical narrative: Cough, intermittent shortness of breath
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No adverse event - patient asymptomatic and no side effect noted after vaccine  Excess varicella vaccine administered. Proquad adminisitered in place of intended MMR vaccine.  Error reported to provider and Agency unit. Advised to have parent monitor child closely for next 24 hours. Parent to have patient return for office visit with provider following day for check up.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Limb discomfort
Clinical narrative: The mother called to report that on the day after the vaccine administration when she picked her son up from school, he reported discomfort in his right arm.  When she inspected his arm, she reported that the entire upper portion of his right arm to the shoulder was red, warm to the touch, and "bubbly" to the touch.   She reported that the patient otherwise felt fine and did not have a fever or lethargy.    The mother was advised to take the patient to the doctor/ urgent care for assessment and that she could apply a cool compress to the area.  She was advised that the clinic would contact her back to follow up.  A voice message was left at 10:40 am requesting a return call.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: lightheaded, dizziness, redness around injection site with swelling, warmth, and itching associated with a fever.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: lightheaded, dizziness, redness around injection site with swelling, warmth, and itching associated with a fever.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Patient received both vaccines. She informed mom did not feel well. After mother received a vaccine, the patient passed out. Parents left with daughter in arms. Father would not allow pharmacist nor customer service to provide medical attention. Family left in vehicle and drove to hospital. Pharmacist followed up with mother to ask how patient was doing. She was checked into hospital and receiving medical attention.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired dose of Infanrix on August 27th 2024. Dose expired on April 21st 2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   Concomitant products included Pediarix.   On 27-AUG-2024, the patient received the 1st dose of Infanrix. On 27-AUG-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired dose of Infanrix on August 27th 2024. Dose expired on April 21st 2024.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported they accidentally administered an expired dose of Infanrix, which led expired vaccine used. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Patient notices arm started to swell two days after receiving vaccination (09/03)
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Clinical member accidentally administered sterile water instead of vaccine. Patient was brought back in and given correct vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reported a rash along her chest that is radiating and red. This is the second time this has occurred from the COVID-19 vaccine.  Patient did not require hospitalization. Advised patient if it gets worse or causes swelling of the mouth, tongue or throat to go to the emergency room.  Advised patient to take benadryl 25mg every 6 hours until rash is resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extreme chills, fatigue for greater then eight hours. Victim had down vest, jacket, blanket, heating padding and hot beverage to try and stay warm.  Victim also had injection site reaction including redness, red spots and swelling, warm to the touch
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Bursitis, Injection site pain, Pain, Swelling
Clinical narrative: Patient presented to the clinic with a complaint of left shoulder after receiving Tdap vaccine 8 days prior. He remembers that the injection was given into the deltoid muscle but the pain started to his left shoulder in the subacromial region. There is no pain when stationed but when has pain when he tries to lift up his left arm. Denies swelling, fever, chills.  -Pt likely developed subacromial bursitis secondary to post vaccine swelling.  - Rest and alternate ice and heat - Take ibuprofen - No need for re-vaccination subacromial bursitis of left shoulder secondary to Tdap vaccination.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperhidrosis, Muscle spasms
Clinical narrative: Abdominal cramping, muscle spasms, convulsions, sweating/chills, diarrhea.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Abdominal cramping, muscle spasms, convulsions, sweating/chills, diarrhea.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The patient presented to a vaccination clinic and requested the RSV vaccine. It was later noted that she had already received a dose of the same RSV vaccine on 10/21/23
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: left thigh erythema and swelling 10cm x13 cm
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash
Clinical narrative: Twenty minutes after the patient received the vaccine, she refers itchiness and rash in the back, the chest and the neck.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administered high on the right shoulder; likely entering subacromial bursa area.
Age: 6.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaxelis  was given to patient at the age of 6 years old.
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Cardiovascular evaluation, Computerised tomogram, Confusional state, Lumbar puncture
Clinical narrative: ASEPTIC MENINGITIS - acute confusion, fever, generalized weakness
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Meningitis aseptic, Pyrexia
Clinical narrative: ASEPTIC MENINGITIS - acute confusion, fever, generalized weakness
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: The patient was given the Flublok vaccine at the age of 16 when this vaccine is only approved for 18 years and older. The error was caught by the safety team . The system did not block the process when the vaccine was entered nor did the pharmacist. The patient's mother was contacted by myself and was told that her daughter received a flu shot that was for patients 18 and older. The mother stated her daughter seemed fine and appreciated us contacting them and making them aware
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left thigh with induration and erythema. 9.2cm wide x 6.4cm length.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cold sweat, Fatigue, Loss of consciousness
Clinical narrative: MILD/BRIEF LOC AFTER FINAL IMMUNIZATION, NO INJURY, WAS IN MOTHER'S LAP. AWOKE SPONTANEOUSLY, CLAMMY AND FATIGUED. REPORTED HAD NOT HAD BREAKFAST. SUCKER AND COOL DRINKING WATER GIVEN, COLD DAMP TOWEL APPLIED. AMBULATED FROM CLINIC WITHOUT DIFFICULTY
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscle strain, Myalgia
Clinical narrative: severe headache, muscle aches, strain,
Age: 56.0
Sex: M
Vaccine: HEP, TDAP, VARZOS
Symptoms: Confusional state, Dizziness, Fall, Hyperhidrosis, Pallor
Clinical narrative: Following administration of Shingrix, Boostrix, and Energix-B, the patient reported feeling light-headed and appeared pale. We provided him with water and a lollipop to stabilize his condition. After 3-4 minutes, the patient remained pale and we advised him to stay seated for a few more minutes before standing. However, despite this advice, he stood up and attempted to leave. As the patient walked down the hall, he slowly started to lean against the hallway and fall to the floor. We immediately intervened, instructing him to extend his legs and remain still. We also provided a fan to cool him down and placed an ice pack on his neck. Additionally, we administered glucose tablets as he exhibited signs of confusion and sweating. The patient was apologetic and confused. He insisted that he was feeling fine and expressed a desire to leave. We informed him that he had experienced a vasovagal response and advised him to remain seated on the floor for at least another 15 minutes. After approximately 5 minutes, he stated that he felt well enough to wait in his car, though we strongly recommended that he remain seated for another 15 minutes to ensure his safety. Despite our advice, the patient refused and chose to wait in his car. We reminded him not to drive for at least 15 minutes and to keep the air conditioning on. We observed the patient in his vehicle for about 7 minutes, at which point he left the premises.
Age: 56.0
Sex: M
Vaccine: HEP, TDAP, VARZOS
Symptoms: Presyncope
Clinical narrative: Following administration of Shingrix, Boostrix, and Energix-B, the patient reported feeling light-headed and appeared pale. We provided him with water and a lollipop to stabilize his condition. After 3-4 minutes, the patient remained pale and we advised him to stay seated for a few more minutes before standing. However, despite this advice, he stood up and attempted to leave. As the patient walked down the hall, he slowly started to lean against the hallway and fall to the floor. We immediately intervened, instructing him to extend his legs and remain still. We also provided a fan to cool him down and placed an ice pack on his neck. Additionally, we administered glucose tablets as he exhibited signs of confusion and sweating. The patient was apologetic and confused. He insisted that he was feeling fine and expressed a desire to leave. We informed him that he had experienced a vasovagal response and advised him to remain seated on the floor for at least another 15 minutes. After approximately 5 minutes, he stated that he felt well enough to wait in his car, though we strongly recommended that he remain seated for another 15 minutes to ensure his safety. Despite our advice, the patient refused and chose to wait in his car. We reminded him not to drive for at least 15 minutes and to keep the air conditioning on. We observed the patient in his vehicle for about 7 minutes, at which point he left the premises.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Pt received 3 vaccines at physician's office on Wednesday, 2 in left leg. Pt developed slight tactile fever, a mild rash on her stomach/back, and redness/swelling at injection site. on Thursday. Doubled in size by Friday. Pt came to rapid access clinic on Friday. Zyrtec prescribed.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Swelling
Clinical narrative: patient began swelling and rash developed. applied ice and symptoms began to resolve
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Gave an extra Pfizer Comirnaty Covid Vaccine instead of high dose fluad shot. Patient is fine. No adverse side effects out of the norm of a sore arm. Was not angry and is coming back for the correct fluad vaccine today or this weekend. Reporting to cover all areas.
Age: 46.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain upper, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood creatinine normal
Clinical narrative: Severe RUQ abdominal pain, onset September 1, 2024 approximately 16:15 pm, day 4 following vaccinations for yellow fever and typhoid, associated with nausea and dry retching. Required evaluation in the Emergency Department. Labs showed mild elevation in WBC and ANC. Urinalysis negative for blood; elevated specific gravity, trace ketones. Afebrile. CT abdomen/pelvis showed hepatomegaly; no other abnormalities, gallbladder normal.  Required morphine and hydromorphone (multiple doses) for pain control plus ondansetron, ketorolac, metoclopramide, dicycloverine, pantoprazole. Total duration of pain 8 hours. Unknown outcome, awaiting outpatient imaging followup.
Age: 46.0
Sex: F
Vaccine: TYP, YF
Symptoms: Blood urea increased, Computerised tomogram abdomen abnormal, Full blood count abnormal, Haemoglobin, Hepatomegaly
Clinical narrative: Severe RUQ abdominal pain, onset September 1, 2024 approximately 16:15 pm, day 4 following vaccinations for yellow fever and typhoid, associated with nausea and dry retching. Required evaluation in the Emergency Department. Labs showed mild elevation in WBC and ANC. Urinalysis negative for blood; elevated specific gravity, trace ketones. Afebrile. CT abdomen/pelvis showed hepatomegaly; no other abnormalities, gallbladder normal.  Required morphine and hydromorphone (multiple doses) for pain control plus ondansetron, ketorolac, metoclopramide, dicycloverine, pantoprazole. Total duration of pain 8 hours. Unknown outcome, awaiting outpatient imaging followup.
Age: 46.0
Sex: F
Vaccine: TYP, YF
Symptoms: Nausea, Neutrophil count increased, Pelvic fluid collection, Platelet count normal, Retching
Clinical narrative: Severe RUQ abdominal pain, onset September 1, 2024 approximately 16:15 pm, day 4 following vaccinations for yellow fever and typhoid, associated with nausea and dry retching. Required evaluation in the Emergency Department. Labs showed mild elevation in WBC and ANC. Urinalysis negative for blood; elevated specific gravity, trace ketones. Afebrile. CT abdomen/pelvis showed hepatomegaly; no other abnormalities, gallbladder normal.  Required morphine and hydromorphone (multiple doses) for pain control plus ondansetron, ketorolac, metoclopramide, dicycloverine, pantoprazole. Total duration of pain 8 hours. Unknown outcome, awaiting outpatient imaging followup.
Age: 46.0
Sex: F
Vaccine: TYP, YF
Symptoms: Scan with contrast abnormal, Specific gravity urine increased, Urine ketone body present, White blood cell count increased
Clinical narrative: Severe RUQ abdominal pain, onset September 1, 2024 approximately 16:15 pm, day 4 following vaccinations for yellow fever and typhoid, associated with nausea and dry retching. Required evaluation in the Emergency Department. Labs showed mild elevation in WBC and ANC. Urinalysis negative for blood; elevated specific gravity, trace ketones. Afebrile. CT abdomen/pelvis showed hepatomegaly; no other abnormalities, gallbladder normal.  Required morphine and hydromorphone (multiple doses) for pain control plus ondansetron, ketorolac, metoclopramide, dicycloverine, pantoprazole. Total duration of pain 8 hours. Unknown outcome, awaiting outpatient imaging followup.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given another patient's vaccinations. Was given Hep A and MMRV out of cycle. Patient felt fine when leaving clinic, MA didn't realize mistake till patient had left for the day.
Age: 44.0
Sex: F
Vaccine: CHIK
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient stated she a headache, low grade fever, achy joints ( spine, neck) and was fatigued 5 days after receiving the vaccine. On day 6 the headache and fever were gone, she felt more energetic, but still felt " stiff and achy" in her joints. I called patient again on day 7 after being vaccinated and she stated that all her symptoms were gone.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal distension, Appetite disorder, Dyspnoea, Flatulence, Peripheral swelling
Clinical narrative: She got her vaccine, later on her hands started swelling, her abdomen, face, hands and feet starting swelling and are still swollen.  She has gas all day throughout the day and night.  She called the pharmacy and was told to go to see her PCP and get a steroid shot.  She saw her doctor about her symptoms, and told her what the pharmacy said and they would not give her the shot.  She was not given anything to treat her symptoms.  She went to the ER on 7/29/24 to Hospital due to her reaction to the vaccine, she was having problems breathing, and feeling short of breath.  They gave her a shot of something, and was given an inhaler to use when she felt short of breath.  She stays hungry all the time and wants to know why.  She had never been that way in the past prior to the vaccine.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Swelling face
Clinical narrative: She got her vaccine, later on her hands started swelling, her abdomen, face, hands and feet starting swelling and are still swollen.  She has gas all day throughout the day and night.  She called the pharmacy and was told to go to see her PCP and get a steroid shot.  She saw her doctor about her symptoms, and told her what the pharmacy said and they would not give her the shot.  She was not given anything to treat her symptoms.  She went to the ER on 7/29/24 to Hospital due to her reaction to the vaccine, she was having problems breathing, and feeling short of breath.  They gave her a shot of something, and was given an inhaler to use when she felt short of breath.  She stays hungry all the time and wants to know why.  She had never been that way in the past prior to the vaccine.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product preparation error, Product storage error
Clinical narrative: I was unaware that we let vaccine defrost all the way. It was my first time giving Monkeypox vaccine.  I diluted vaccine with a prefilled sterile diluent we have in clinic. We use same diluent for our other frozen vaccines such as Varicella and MMRV.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Feeling abnormal, Neck pain, Pain in extremity
Clinical narrative: arm very sore, shoulder and neck /tricept area is swollen. he said it feels like it on fire, and he can't sleep. he said he doesn't have a fever, just feels very poorly.  explained he should go to his doctor, he refused.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: arm very sore, shoulder and neck /tricept area is swollen. he said it feels like it on fire, and he can't sleep. he said he doesn't have a fever, just feels very poorly.  explained he should go to his doctor, he refused.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: Every time I received a covid vaccine, regardless of manufacturer, I experience the same sort of symptoms of Sertraline withdrawal that I would if I were to go a few days without taking it ("brain zaps"). It is nothing debilitating but thought it would be of interest to report. They usually go away after 48 hours.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Fatigue, SARS-CoV-2 test, Sinus operation
Clinical narrative: Sinus drainage, cough, fatigue
Age: 49.0
Sex: M
Vaccine: HPV9
Symptoms: Product prescribing issue
Clinical narrative: client came in with a prescription from his primary physician for HPV vaccine
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient administered Pediarix and Engerix . Both vaccine's are Hep B. Family contacted by Dr.  No known side effects at time of report.
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Refusal of vaccination
Clinical narrative: Patient did not consent to receive the Hep B vaccine which was administered. Patient donates plasma and now will need to undergo serological testing before she can donate plasma again.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient came in wanting an RSV vaccine. Stated he had not had one and Dr wanted him to get it. The vaccine was administered. Today it came to the pharmacy's attention that he did in fact have a dos e in 2023. This dose was unnecessary.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was given high dose influenza when she under age of 65
Age: 54.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Back pain, Chills, Inappropriate schedule of product administration, Neck pain, Pyrexia
Clinical narrative: Back pain; Neck pain; Spine pain; due to Covid she did not get the 2nd dose; Fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Tetanus vaccine for prophylaxis.   Previously administered products included Shingrix (1st dose in 2020).   On 27-AUG-2024, the patient received the 2nd dose of Shingrix (intercostal, left arm) and Tetanus vaccine (left arm). In AUG-2024, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and chills (Verbatim: Chills). On 27-AUG-2024, the patient experienced back pain (Verbatim: Back pain), neck pain (Verbatim: Neck pain), pain in spine (Verbatim: Spine pain) and social problem (Verbatim: due to Covid she did not get the 2nd dose). The outcome of the fever and chills were not reported and the outcome of the back pain, neck pain, pain in spine and social problem were unknown.   It was unknown if the reporter considered the fever, chills, back pain, neck pain and pain in spine to be related to Shingrix.     It was unknown if the company considered the fever, chills, back pain, neck pain and pain in spine to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2024 The patient got the 1st dose of Shingrix vaccine in 2020 and due to covid she did not get the 2nd dose, which led social problem. The patient had pain in the spine, back and neck pain. The patient did not know if it was related to the Shingrix or to the tetanus vaccine. The patient thought it was due to Shingrix vaccine.  The patient also reports having chills and fever. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Spinal pain
Clinical narrative: Back pain; Neck pain; Spine pain; due to Covid she did not get the 2nd dose; Fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Tetanus vaccine for prophylaxis.   Previously administered products included Shingrix (1st dose in 2020).   On 27-AUG-2024, the patient received the 2nd dose of Shingrix (intercostal, left arm) and Tetanus vaccine (left arm). In AUG-2024, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and chills (Verbatim: Chills). On 27-AUG-2024, the patient experienced back pain (Verbatim: Back pain), neck pain (Verbatim: Neck pain), pain in spine (Verbatim: Spine pain) and social problem (Verbatim: due to Covid she did not get the 2nd dose). The outcome of the fever and chills were not reported and the outcome of the back pain, neck pain, pain in spine and social problem were unknown.   It was unknown if the reporter considered the fever, chills, back pain, neck pain and pain in spine to be related to Shingrix.     It was unknown if the company considered the fever, chills, back pain, neck pain and pain in spine to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2024 The patient got the 1st dose of Shingrix vaccine in 2020 and due to covid she did not get the 2nd dose, which led social problem. The patient had pain in the spine, back and neck pain. The patient did not know if it was related to the Shingrix or to the tetanus vaccine. The patient thought it was due to Shingrix vaccine.  The patient also reports having chills and fever. The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms
Clinical narrative: SPASMS IN THE LEG
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Pain in extremity
Clinical narrative: Pt reported arm soreness and redness the following day of vaccination 9/5/24. Also felt as though she had a fever, but did not check temperature. Patient also experienced unusual amount of fatigue
Age: 16.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Pallor, Posture abnormal
Clinical narrative: Client was seated during vaccine administration and was calm during administration of all vaccines. Immediately after I administered the last vaccine, MMR SQ right arm, and discarded the needle, I turned around to find client still seated, but leaning to his right side against his older brother. Client observed with bilateral muscle jerking up upper extremities and eyes rolled back. This lasted approximately 5 seconds, with client responding quickly to tactile and verbal cues. Face was visibly pale. Client given & tolerated juice to drink, then walked with standby assistance to exam bed to rest supine with legs elevated. BP 124/78, HR 80. Client was monitored for 10 minutes in this position, alert and oriented x3.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized burning pain, redness, warmth, and swelling at the site fifteen minutes after injection.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Animal scratch, No adverse event, Product dispensing issue
Clinical narrative: PT GOT A SCRATCH BY A DOG WHILE TRAVELING 8/26/24, GOT 1 SHOT ,.. MISSED THE 2ND SHOT WHILE TRAVELING WHEN SHE'S BACK HOME, HER MD TOLD HER SHOULD GET 2 MORE SHOTS EVEN THOUGH IT'S PAST THE SCHEDULE OF THE 3 RD DAY OF  INCIDENT ON 9/1.  GAVE HER  THE 2ND SHOT AS RECOMMENDED BY HER MD.   THE NEXT DAY, PHARMACY MANAGER STATED  WE CAN'T ADMINISTERD POST EXPOSURE,  PHARMACY CAN ONLY ADMINISTER PRE EXPOSURE, BUT WE CAN DISPSENSE IT AND BE ADMINISTER BY DOCTOR.   PT CALLED 9/3, NO SIDE EFFECTS REPORTED, INFORMED HER TO CALL MD TO SEND IN RX FOR THE 3RD DOSE AND HAVE MD ADMINISTER THE SHOT.  PT AGREED
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Illness, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Woke on Tuesday morning with a very sore throat and then developed into bad cold with sinus issues and headache and aches and pains. Very congested with lots of mucus.  It is now day  7 since I had the vaccine and still feeling very sick. I am POSITIVE that I was 100% healthy when I received this vaccine and that the Covid vaccine caused this horrible illness that I have been experiencing for the last 7 days . I will not be receiving any more  Covid vaccines after this
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Respiratory tract congestion, Secretion discharge, Sinus disorder
Clinical narrative: Woke on Tuesday morning with a very sore throat and then developed into bad cold with sinus issues and headache and aches and pains. Very congested with lots of mucus.  It is now day  7 since I had the vaccine and still feeling very sick. I am POSITIVE that I was 100% healthy when I received this vaccine and that the Covid vaccine caused this horrible illness that I have been experiencing for the last 7 days . I will not be receiving any more  Covid vaccines after this
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Headache
Clinical narrative: received 3rd shot of Shingrix, patient is kinda off, tired and has a headache, but that is how he is normally.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site pain that was red, painful, warm to the touch and the area expanded. Also, rapid heart beat.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Patient was in the vaccine booth sitting in the armed chair. The pharmacist had just given Spikevax vaccine into his left deltoid, when the patient turned his head to the right, passed out, and slumped into his chair. He was very pale and diaphoretic. I immediately notified pharmacy staff to call code white. I also stepped to the patient's right side to provide support, and tried rubbing his shoulder and calling his name to arouse him. He quickly became conscious and was able look at me directly and tell me he was at pharmacy. Once he came to, he passed out again, and I did the same things to arouse him. He did arouse again the second time. I told him to take some deep breaths and then I placed his feet up in a chair close by. We provided water and a cold compress, and paged his mom to pharmacy. She spoke with me and said he actually had a history of passing out, although this was not indicated on his Patient Questionnaire. Management team was available to process the event. He started to feel better and the color returned to his face and said he was feeling "a 7 out of 10". Mom went to grab him something to eat and was able to finish a sandwich/drink. I encouraged him to sit for at least 30 minutes total. The patient ended up feeling better, and left walking out of the pharmacy area with his mom.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Circumstance or information capable of leading to medication error, Injection site haemorrhage, Scratch, Underdose
Clinical narrative: When administering vaccine patient grabbed syringe and pulled it out of arm.  As patient pulled syringe out the needle scraped again the patients right deltoid region.  Most of the vaccine was administered but not all.  The patient bled a small amount. Pressure was applied to the area and attempted to apply a bandage, but patient was too averse to the adhesive material.  Provider viewed patient's injury and deemed minor.  Patient's mother was advised signs and symptoms to watch out for and notified to call if they have any concerns.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dysphagia, Headache, Myalgia, Neck pain
Clinical narrative: Within 15 minutes of shot - vision problems, light sensitivity, swallowing problems, pain in neck and shoulders, then headache lasting 18 hours, muscle and joint pain also for 18 hours.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Visual impairment
Clinical narrative: Within 15 minutes of shot - vision problems, light sensitivity, swallowing problems, pain in neck and shoulders, then headache lasting 18 hours, muscle and joint pain also for 18 hours.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Arthritis, Erythema, Feeling abnormal, Palmar erythema
Clinical narrative: Within 30 minutes of receiving the vaccination both hand palms and the bottom of both feet turned bright red and starting itching. The itching was unbearable. Concurrently, severe joint pain started in my right arm that was different from any of the past 8 COVID vaccines I had ever received. I have OA in my joints from wear and have had rotator cuff surgeries in both shoulders. Additionally, I have damage to my right wrist and thumb for decades of construction work. I also suffer from an autoimmune condition known as PMR that attacks my joints and the reaction I had was very reminiscent of a flare up episode from PMR. Initially, the pain was most prominent in those two areas specifically, but by the middle of the first night all my major joints were inflamed and in intense pain. I took a half dose of Tramadol and that reduced it enough to allow me to finally fall asleep at 4am. Today is 48 hours after the vaccinations and I am feeling nearly back to normal with some residual joint pain and visible swelling.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Pruritus, Sleep disorder, Swelling
Clinical narrative: Within 30 minutes of receiving the vaccination both hand palms and the bottom of both feet turned bright red and starting itching. The itching was unbearable. Concurrently, severe joint pain started in my right arm that was different from any of the past 8 COVID vaccines I had ever received. I have OA in my joints from wear and have had rotator cuff surgeries in both shoulders. Additionally, I have damage to my right wrist and thumb for decades of construction work. I also suffer from an autoimmune condition known as PMR that attacks my joints and the reaction I had was very reminiscent of a flare up episode from PMR. Initially, the pain was most prominent in those two areas specifically, but by the middle of the first night all my major joints were inflamed and in intense pain. I took a half dose of Tramadol and that reduced it enough to allow me to finally fall asleep at 4am. Today is 48 hours after the vaccinations and I am feeling nearly back to normal with some residual joint pain and visible swelling.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Condition aggravated, Erythema, Pain in extremity, Palmar erythema
Clinical narrative: Within 30 minutes of receiving the vaccination both hand palms and the bottom of both feet turned bright red and starting itching. The itching was unbearable. Concurrently, severe joint pain started in my right arm that was different from any of the past 8 COVID vaccines I had ever received. I have OA in my joints from wear and have had rotator cuff surgeries in both shoulders. Additionally, I have damage to my right wrist and thumb for decades of construction work. I also suffer from an autoimmune condition known as PMR that attacks my joints and the reaction I had was very reminiscent of a flare up episode from PMR. Initially, the pain was most prominent in those two areas specifically, but by the middle of the first night all my major joints were inflamed and in intense pain. I took a half dose of Tramadol and that reduced it enough to allow me to finally fall asleep at 4am. Today is 48 hours after the vaccinations and I am feeling nearly back to normal with some residual joint pain and visible swelling.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Polyarthritis, Polymyalgia rheumatica, Pruritus, Swelling
Clinical narrative: Within 30 minutes of receiving the vaccination both hand palms and the bottom of both feet turned bright red and starting itching. The itching was unbearable. Concurrently, severe joint pain started in my right arm that was different from any of the past 8 COVID vaccines I had ever received. I have OA in my joints from wear and have had rotator cuff surgeries in both shoulders. Additionally, I have damage to my right wrist and thumb for decades of construction work. I also suffer from an autoimmune condition known as PMR that attacks my joints and the reaction I had was very reminiscent of a flare up episode from PMR. Initially, the pain was most prominent in those two areas specifically, but by the middle of the first night all my major joints were inflamed and in intense pain. I took a half dose of Tramadol and that reduced it enough to allow me to finally fall asleep at 4am. Today is 48 hours after the vaccinations and I am feeling nearly back to normal with some residual joint pain and visible swelling.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Arthritis, Erythema, Feeling abnormal, Palmar erythema
Clinical narrative: PATIENT CALLED ON 9/6/24 TO REPORT THAT SHE EXPERIENCED ITCHY PALMS AND FEET ABOUT 15 MINUTES AFTER GETTING THE VACCINE. SHE SAID HER ARM HURT FROM SHOULDER TO HAND STARTING EVENING OF,  BY MIDNIGHT IMPACTING ARHTHRITIC JOINTS .SHE FELT A LITTLE BETTER /SWELLING GOING DOWN BY 9/6/24, POLYARTHRALGIA RHEUMATICAL SEEMS TO HAVE BEEN TRIGGERED. NO RASH EXCEPT REDNESS ON PALMS AND FEET. TOOK BENADYL FOR ITCHING, TRAMADOL AND NAPROXEN FOR PAIN.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Pruritus, Sleep disorder, Swelling
Clinical narrative: PATIENT CALLED ON 9/6/24 TO REPORT THAT SHE EXPERIENCED ITCHY PALMS AND FEET ABOUT 15 MINUTES AFTER GETTING THE VACCINE. SHE SAID HER ARM HURT FROM SHOULDER TO HAND STARTING EVENING OF,  BY MIDNIGHT IMPACTING ARHTHRITIC JOINTS .SHE FELT A LITTLE BETTER /SWELLING GOING DOWN BY 9/6/24, POLYARTHRALGIA RHEUMATICAL SEEMS TO HAVE BEEN TRIGGERED. NO RASH EXCEPT REDNESS ON PALMS AND FEET. TOOK BENADYL FOR ITCHING, TRAMADOL AND NAPROXEN FOR PAIN.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Condition aggravated, Erythema, Pain in extremity, Palmar erythema
Clinical narrative: PATIENT CALLED ON 9/6/24 TO REPORT THAT SHE EXPERIENCED ITCHY PALMS AND FEET ABOUT 15 MINUTES AFTER GETTING THE VACCINE. SHE SAID HER ARM HURT FROM SHOULDER TO HAND STARTING EVENING OF,  BY MIDNIGHT IMPACTING ARHTHRITIC JOINTS .SHE FELT A LITTLE BETTER /SWELLING GOING DOWN BY 9/6/24, POLYARTHRALGIA RHEUMATICAL SEEMS TO HAVE BEEN TRIGGERED. NO RASH EXCEPT REDNESS ON PALMS AND FEET. TOOK BENADYL FOR ITCHING, TRAMADOL AND NAPROXEN FOR PAIN.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Polyarthritis, Polymyalgia rheumatica, Pruritus, Swelling
Clinical narrative: PATIENT CALLED ON 9/6/24 TO REPORT THAT SHE EXPERIENCED ITCHY PALMS AND FEET ABOUT 15 MINUTES AFTER GETTING THE VACCINE. SHE SAID HER ARM HURT FROM SHOULDER TO HAND STARTING EVENING OF,  BY MIDNIGHT IMPACTING ARHTHRITIC JOINTS .SHE FELT A LITTLE BETTER /SWELLING GOING DOWN BY 9/6/24, POLYARTHRALGIA RHEUMATICAL SEEMS TO HAVE BEEN TRIGGERED. NO RASH EXCEPT REDNESS ON PALMS AND FEET. TOOK BENADYL FOR ITCHING, TRAMADOL AND NAPROXEN FOR PAIN.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injected limb mobility decreased, Laboratory test, Magnetic resonance imaging, Pain
Clinical narrative: Significant pain in left shoulder at the time of injection. Arm soreness lasting several days, followed by restricted motion and severe shooting pain upon certain movements of the shoulder joint. This last lasted over a year. Initial office visit with PCP was on 10/18/23. This was followed by a referral to an Orthopedic Clinic, with the fist appointment on 11/9/23. Tried physical therapy, starting on 11/9/23) without success. This was followed by the first MRI on 1/5/24.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Differential white blood cell count, Discomfort, Dizziness, Echocardiogram
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Full blood count, Glycosylated haemoglobin, HIV test
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Hypersomnia, Hypophagia
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Influenza virus test, Nausea, Pain, Pain in extremity
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pruritus, Respiratory syncytial virus test, SARS-CoV-2 test, Somnolence
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test, Syncope, Urticaria, Vomiting
Clinical narrative: The reaction began as a sore arm and achy during first 24 hours after the shot. The next 24 hours very tired, light headed and sleepy and went to bed early without eating much dinner. At noon the next day patient was too tired to work, came home and vomited, then laid down to sleep from noon - 10:00 PM. He woke up, tried to stand and became very light headed and fainted. I noticed when he woke up that he had hives all over his body. I started giving him Benadryl 50 Mg every 4 hours. It did alleviate the itching somewhat, but not a lot, He had no appetite and did not eat dinner at all. He did not sleep well at all that night. When he got up the next morning he was again covered with hives and started vomiting. He had very little food in his stomach but vomited copious amounts of liquid. He fainted again, I couldn't get a good BP reading, so I called 911. The EMT's came and determined due to his discomfort and the nausea we should go to the ER.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Body temperature increased, Cough, Dyspnoea, Feeling hot, Paraesthesia
Clinical narrative: Pt. reported back to clinic at 1540 with c/o tingling, itchiness and "feeling hot'.  Pt. also had cough and stated he felt "short of breath".   Temperature was 100.4F.  Pt. given 50mg of Benadryl PO and was continued to be monitored by Dr.  Dr. noted chest congestion on auscultation and therefore administered Epi Pen 0.3mg in pt. thigh at 1550.  Pt. remained alert and oriented.  Shortly after pt. reported feeling better and was advised to go to ER for further evaluation.  Pt. taken by friend in personal vehicle to ER.  Pt. reported he was being monitored at the ER.